Клинические исследование Crohn

Спонсоры	Ведущий спонсор: AstraZeneca
Источник	AstraZeneca
Краткое содержание	This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Общий статус

Recruiting

Дата начала

2018-12-07

Дата завершения

2027-06-10

Дата первичного завершения

2027-03-04

Фаза

Phase 2/Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Stage 1. Percentage of patients with CDAI remission	at Week 12
Stage 2. Percentage of patients with endoscopic response	at Week 52
Stage 2. Percentage of patients with clinical remission	at Week 52

Вторичный результат

Мера	Временное ограничение
Stage 1. Percentage of patients with endoscopic response	at Week 12
Stage 1. Percentage of patients with clinical remission	at Week 12
Stage 1. Percentage of patients with CDAI response	at Week 12
Stage 1. Percentage of patients with CDAI remission	at both Week 12 and Week 52
Stage 1. Percentage of patients with CDAI response	at both Week 12 and Week 52
Stage 1. Percentage of patients with endoscopic response	at both Week 12 and Week 52
Stage 1. Percentage of patients with clinical remission	at both Week 12 and Week 52
Stage 1. Percentage of patients with endoscopic remission	at Week 52
Stage 1. Percentage of patients with clinical remission	at Week 52
Stage 1. Percentage of patients with CDAI response	at Week 52
Stage 1. Percentage of patients with CDAI remission	at Week 52
Stage 1. Percentage of patients with endoscopic response	at Week 52
Stage 1. Percentage of patients with SES-CD total score of 0-2	at Week 52
Stage 1. Percentage of patients with endoscopic response and endoscopic remission	Endoscopic response at Week 12, endoscopic remission at Week 52
Stage 1. Serum concentration of brazikumab	Through Week 68
Stage 1. Incidence of anti-drug antibodies	Through Week 68
Stage 1. Exposure-response	Through Week 68
Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2	at Week 12
Stage 1. Number and percentage of patients with adverse events	Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in laboratory values	Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in vital signs	Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in physical exams	Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in ECGs	Through Week 68
Stage 2. Percentage of patients with endoscopic response	at both Week 12 and Week 52
Stage 2. Percentage of patients with clinical remission	at both Week 12 and Week 52
Stage 2: Percentage of patients with endoscopic remission	at Week 52
Stage 2. Percentage of patients with clinical remission	at Week 52
Stage 2: Percentage of patients with CS-free endoscopic remission	at Week 52
Stage 2. Percentage of patients with CS-free clinical remission	at Week 52
Stage 2: Percentage of patients with CS-free endoscopic remission	at Week 52
Stage 2: Percentage of patients with CS-free clinical remission	at Week 52
Stage 2. Percentage of patients with endoscopic response	at Week 12
Stage 2. Percentage of patients with clinical remission	at Week 12
Stage 2. Percentage of patients with endoscopic response and endoscopic remission	Endoscopic response at Week 12, endoscopic remission at Week 52
Stage 2. Percentage of patients with clinical remission	at both Week 12 and Week 52
Stage 2. Percentage of patients achieving CS-free endoscopic response	at Week 52
Stage 2. Percentage of patients with clinical remission	at Week 52
Stage 2. Serum concentration of brazikumab	Through Week 68
Stage 2. Incidence of anti-drug antibodies	Through Week 68
Stage 2. Exposure-response	Through Week 68
Stage 2. Number and percentage of patients with adverse events	Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in laboratory values	Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in vital signs	Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in physical exams	Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in ECGs	Through Week 68

Регистрация

928

Состояние	Crohn's Disease IBD
Вмешательство	Тип вмешательства: Drug Название вмешательства: Brazikumab low dose Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Тип вмешательства: Drug Название вмешательства: Brazikumab high dose Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Тип вмешательства: Drug Название вмешательства: Humira® Описание: Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50. Этикетка Arm Group: (Stage 2) Humira® Тип вмешательства: Drug Название вмешательства: Placebo Описание: Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48 Этикетка Arm Group: (Stage 1) Placebo
Приемлемость	Критерии: Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however, participants enrolled in Stage 1 will not be permitted to enroll in Stage 2. Inclusion Criteria: 1. At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive. 2. A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings. 3. Moderately to severely active CD defined by a CDAI score of 220 to 450 AND; CDAI LSF score ≥ 5 OR CDAI AP score ≥ 2; AND SES-CD of at least 6 4. Participant had an inadequate response or intolerance to intervention with conventional treatment [oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine], or prior biological treatment, or demonstrated CS dependence for the treatment of CD. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action. 5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable dose. 6. No known history of active TB or latent TB without completion of appropriate intervention. Acceptable TB test results from the central laboratory must be met. 7. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention. 8. Women not of childbearing potential are defined as women who are either permanently sterilized or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause. 9. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks. 10. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. 11. Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period. 12. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Complete inclusion criteria are in the study protocol Exclusion Criteria: 1. Participant is unable or unwilling to have endoscopic procedures performed during the study. 2. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption. 3. History of toxic megacolon within 3 months prior to Randomization. 4. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma, ostomy, or extensive colonic resection are excluded. 5. Participant has an enterocutaneous or enterovesicular fistula. Participants with other active fistulas, including perianal fistulas, may be considered for enrollment if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess). 6. Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening. 7. Complications of CD including short bowel syndrome, strictures/stenoses with obstruction or pre-stenotic dilation, or conditions where surgery may be anticipated within 6 months, or other conditions that may confound efficacy evaluations for the study. 8. Participant has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclusion criterion, and does not require exclusion). 9. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening. 10. Participant has any of the following related to infections: - Evidence of a recent (within 6 months of Randomization) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment. - Any infection requiring hospitalization or treatment with IV anti-infectives (including antiviral treatment) within 4 weeks of Screening. - Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening - Clinically significant chronic infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening - Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with the Study Physician/designee. - Participant has clinical evidence of or suspected to have an abscess during Screening. - Diagnosis of peritonitis or receiving treatment for peritonitis within 8 weeks prior to Screening - Participant has any underlying condition that predisposes participant to infections - Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy - Signs or symptoms of ongoing infection due to intestinal pathogens 11. Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant. 12. Chronic hepatitis B or C infection. 13. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, includingHIV infection. 14. Prior history of or current diagnosis of a demyelinating disorder. 15. Participant has received the following treatment: - Adalimumab, certolizumab pegol, infliximab, or golimumab: within 8 weeks prior to Randomization - Vedolizumab or ustekinumab within 12 weeks prior to Randomization - Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Randomization - Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy 16. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23. 17. Participants who received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening Visit 1. 18. Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy. 19. Participants received more than 1 dose of IV or intramuscular steroids within 2 weeks prior to Screening Visit 1. 20. Participant received topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to Randomization. 21. Participant received a Bacille Calmette-Guérin vaccination within 12 months of Randomization or any other live vaccine less than 4 weeks prior to Randomization or is planning to receive any such vaccine over the course of the study. 22. Participant has known or suspected history of chronic use of NSAIDs (defined as at least 3 times per week for more than 3 months; not applicable to daily aspirin use up to 325mg per day) and/or opiates, drug, or alcohol abuse. 23. History of cancer with the following exceptions: 1. A history of basal cell carcinoma and/or squamous cell carcinoma of the skin, with apparent successful curative therapy greater than 12 months prior to Screening 2. Carcinoma in situ of the cervix, with apparent successful curative therapy, greater than 12 months prior to Screening. 24. Clinically significant cardiovascular conditions including recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within 6 months of Screening. 25. Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined on central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome). 26. Clinically significant kidney disease 27. Abnormal laboratory results at Screening 28. Other concurrent medical conditions: Participant has known, preexisting, clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, hematological, respiratory or any other system abnormalities that are not associated with CD and are uncontrolled with standard treatment. 29. Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study, or receiving other investigational agent(s) 30. Transfusion of blood, plasma, or platelets within the 30 days prior to Screening. 31. Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly. 32. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals. 33. Previous randomization in the present study. Complete exclusion criteria are in the study protocol Пол: All Минимальный возраст: 18 Years Максимальный возраст: 80 Years Здоровые волонтеры: No

Состояние

Crohn's Disease
IBD

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Brazikumab low dose

Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Тип вмешательства: Drug

Название вмешательства: Brazikumab high dose

Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Тип вмешательства: Drug

Название вмешательства: Humira®

Описание: Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

Этикетка Arm Group: (Stage 2) Humira®

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48

Этикетка Arm Group: (Stage 1) Placebo

Приемлемость

Критерии:

Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however, participants enrolled in Stage 1 will not be permitted to enroll in Stage 2. Inclusion Criteria: 1. At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive. 2. A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings. 3. Moderately to severely active CD defined by a CDAI score of 220 to 450 AND; CDAI LSF score ≥ 5 OR CDAI AP score ≥ 2; AND SES-CD of at least 6 4. Participant had an inadequate response or intolerance to intervention with conventional treatment [oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine], or prior biological treatment, or demonstrated CS dependence for the treatment of CD. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action. 5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable dose. 6. No known history of active TB or latent TB without completion of appropriate intervention. Acceptable TB test results from the central laboratory must be met. 7. Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention. 8. Women not of childbearing potential are defined as women who are either permanently sterilized or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause. 9. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks. 10. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. 11. Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period. 12. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Complete inclusion criteria are in the study protocol Exclusion Criteria: 1. Participant is unable or unwilling to have endoscopic procedures performed during the study. 2. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption. 3. History of toxic megacolon within 3 months prior to Randomization. 4. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma, ostomy, or extensive colonic resection are excluded. 5. Participant has an enterocutaneous or enterovesicular fistula. Participants with other active fistulas, including perianal fistulas, may be considered for enrollment if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess). 6. Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening. 7. Complications of CD including short bowel syndrome, strictures/stenoses with obstruction or pre-stenotic dilation, or conditions where surgery may be anticipated within 6 months, or other conditions that may confound efficacy evaluations for the study. 8. Participant has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclusion criterion, and does not require exclusion). 9. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening. 10. Participant has any of the following related to infections: - Evidence of a recent (within 6 months of Randomization) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment. - Any infection requiring hospitalization or treatment with IV anti-infectives (including antiviral treatment) within 4 weeks of Screening. - Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening - Clinically significant chronic infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening - Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with the Study Physician/designee. - Participant has clinical evidence of or suspected to have an abscess during Screening. - Diagnosis of peritonitis or receiving treatment for peritonitis within 8 weeks prior to Screening - Participant has any underlying condition that predisposes participant to infections - Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy - Signs or symptoms of ongoing infection due to intestinal pathogens 11. Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant. 12. Chronic hepatitis B or C infection. 13. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, includingHIV infection. 14. Prior history of or current diagnosis of a demyelinating disorder. 15. Participant has received the following treatment: - Adalimumab, certolizumab pegol, infliximab, or golimumab: within 8 weeks prior to Randomization - Vedolizumab or ustekinumab within 12 weeks prior to Randomization - Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Randomization - Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy 16. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23. 17. Participants who received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening Visit 1. 18. Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy. 19. Participants received more than 1 dose of IV or intramuscular steroids within 2 weeks prior to Screening Visit 1. 20. Participant received topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to Randomization. 21. Participant received a Bacille Calmette-Guérin vaccination within 12 months of Randomization or any other live vaccine less than 4 weeks prior to Randomization or is planning to receive any such vaccine over the course of the study. 22. Participant has known or suspected history of chronic use of NSAIDs (defined as at least 3 times per week for more than 3 months; not applicable to daily aspirin use up to 325mg per day) and/or opiates, drug, or alcohol abuse. 23. History of cancer with the following exceptions: 1. A history of basal cell carcinoma and/or squamous cell carcinoma of the skin, with apparent successful curative therapy greater than 12 months prior to Screening 2. Carcinoma in situ of the cervix, with apparent successful curative therapy, greater than 12 months prior to Screening. 24. Clinically significant cardiovascular conditions including recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within 6 months of Screening. 25. Prolonged QTcF interval (QTc >450 msec or QTC >480 for participants with bundle branch block; determined on central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome). 26. Clinically significant kidney disease 27. Abnormal laboratory results at Screening 28. Other concurrent medical conditions: Participant has known, preexisting, clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, hematological, respiratory or any other system abnormalities that are not associated with CD and are uncontrolled with standard treatment. 29. Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study, or receiving other investigational agent(s) 30. Transfusion of blood, plasma, or platelets within the 30 days prior to Screening. 31. Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly. 32. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals. 33. Previous randomization in the present study. Complete exclusion criteria are in the study protocol

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

80 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Kathy Bohannon	Study Director	AstraZeneca

Общий контакт

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Расположение

Объект:	Положение дел:
Research Site \| Mesa, Arizona, 85206, United States	Withdrawn
Research Site \| Phoenix, Arizona, 85037, United States	Not yet recruiting
Research Site \| Scottsdale, Arizona, 85258, United States	Withdrawn
Research Site \| Scottsdale, Arizona, 85260, United States	Not yet recruiting
Research Site \| Tucson, Arizona, 85741, United States	Withdrawn
Research Site \| Little Rock, Arkansas, 72212, United States	Completed
Research Site \| Beverly Hills, California, 90211, United States	Withdrawn
Research Site \| Camarillo, California, 93012, United States	Withdrawn
Research Site \| Chula Vista, California, 91911, United States	Active, not recruiting
Research Site \| Garden Grove, California, 92845, United States	Withdrawn
Research Site \| La Mesa, California, 91942, United States	Active, not recruiting
Research Site \| Lancaster, California, 93534, United States	Active, not recruiting
Research Site \| Lincoln, California, 95648, United States	Completed
Research Site \| Los Alamitos, California, 90720, United States	Withdrawn
Research Site \| Los Angeles, California, 90036, United States	Withdrawn
Research Site \| Los Angeles, California, 90073, United States	Withdrawn
Research Site \| Mission Hills, California, 91345, United States	Not yet recruiting
Research Site \| Newport Beach, California, 92660, United States	Not yet recruiting
Research Site \| Northridge, California, 91324, United States	Withdrawn
Research Site \| Poway, California, 92064, United States	Active, not recruiting
Research Site \| San Bernardino, California, 92408, United States	Withdrawn
Research Site \| San Diego, California, 92103, United States	Completed
Research Site \| San Francisco, California, 94127, United States	Withdrawn
Research Site \| Colorado Springs, Colorado, 80907, United States	Active, not recruiting
Research Site \| Colorado Springs, Colorado, 80909, United States	Withdrawn
Research Site \| Boca Raton, Florida, 33487, United States	Terminated
Research Site \| Clearwater, Florida, 33756, United States	Active, not recruiting
Research Site \| Coral Gables, Florida, 33134, United States	Withdrawn
Research Site \| Doral, Florida, 33166, United States	Withdrawn
Research Site \| Gainesville, Florida, 32610, United States	Not yet recruiting
Research Site \| Kissimmee, Florida, 34741, United States	Recruiting
Research Site \| Lakeland, Florida, 33813, United States	Recruiting
Research Site \| Miami, Florida, 33157, United States	Active, not recruiting
Research Site \| Miami, Florida, 33165, United States	Recruiting
Research Site \| Miami, Florida, 33165, United States	Withdrawn
Research Site \| Miami, Florida, 33189, United States	Completed
Research Site \| Naples, Florida, 34102, United States	Not yet recruiting
Research Site \| New Port Richey, Florida, 34653, United States	Recruiting
Research Site \| Ocoee, Florida, 34761, United States	Withdrawn
Research Site \| Pensacola, Florida, 32503, United States	Not yet recruiting
Research Site \| Saint Petersburg, Florida, 33709, United States	Not yet recruiting
Research Site \| Saint Petersburg, Florida, 33710, United States	Completed
Research Site \| Tampa, Florida, 33606, United States	Active, not recruiting
Research Site \| Tampa, Florida, 33614, United States	Active, not recruiting
Research Site \| Tampa, Florida, 33615, United States	Not yet recruiting
Research Site \| Tampa, Florida, 33626, United States	Completed
Research Site \| Atlanta, Georgia, 30328, United States	Completed
Research Site \| Atlanta, Georgia, 30342, United States	Not yet recruiting
Research Site \| Decatur, Georgia, 30033, United States	Recruiting
Research Site \| Suwanee, Georgia, 30024, United States	Withdrawn
Research Site \| Arlington Heights, Illinois, 60005, United States	Withdrawn
Research Site \| Gurnee, Illinois, 60031, United States	Withdrawn
Research Site \| Oak Lawn, Illinois, 60453, United States	Not yet recruiting
Research Site \| Springfield, Illinois, 62702, United States	Not yet recruiting
Research Site \| Brownsburg, Indiana, 46112, United States	Completed
Research Site \| New Albany, Indiana, 47150, United States	Withdrawn
Research Site \| Iowa City, Iowa, 52242, United States	Active, not recruiting
Research Site \| Shawnee Mission, Kansas, 66226, United States	Withdrawn
Research Site \| Topeka, Kansas, 66606, United States	Active, not recruiting
Research Site \| Marrero, Louisiana, 70072, United States	Active, not recruiting
Research Site \| New Orleans, Louisiana, 70121, United States	Active, not recruiting
Research Site \| Baltimore, Maryland, 21202, United States	Recruiting
Research Site \| Glen Burnie, Maryland, 21061, United States	Not yet recruiting
Research Site \| Rockville, Maryland, 20850, United States	Withdrawn
Research Site \| Chesterfield, Michigan, 48047, United States	Active, not recruiting
Research Site \| Farmington Hills, Michigan, 48334, United States	Withdrawn
Research Site \| Rochester, Minnesota, 55905, United States	Not yet recruiting
Research Site \| Biloxi, Mississippi, 39532, United States	Withdrawn
Research Site \| Saint Louis, Missouri, 63141, United States	Active, not recruiting
Research Site \| Lincoln, Nebraska, 68505, United States	Withdrawn
Research Site \| Papillion, Nebraska, 68046, United States	Withdrawn
Research Site \| Henderson, Nevada, 89052, United States	Withdrawn
Research Site \| Las Vegas, Nevada, 89106, United States	Withdrawn
Research Site \| Las Vegas, Nevada, 89123, United States	Completed
Research Site \| Albuquerque, New Mexico, 87108, United States	Completed
Research Site \| Brooklyn, New York, 11218, United States	Active, not recruiting
Research Site \| Brooklyn, New York, 11235, United States	Active, not recruiting
Research Site \| New York, New York, 10016, United States	Active, not recruiting
Research Site \| New York, New York, 10016, United States	Withdrawn
Research Site \| Rochester, New York, 14642, United States	Not yet recruiting
Research Site \| Sunnyside, New York, 11104, United States	Active, not recruiting
Research Site \| Greenville, North Carolina, 27834, United States	Recruiting
Research Site \| Morehead City, North Carolina, 28557, United States	Active, not recruiting
Research Site \| Beachwood, Ohio, 44122, United States	Completed
Research Site \| Beavercreek, Ohio, 45431, United States	Withdrawn
Research Site \| Beavercreek, Ohio, 45440, United States	Withdrawn
Research Site \| Cincinnati, Ohio, 45219, United States	Withdrawn
Research Site \| Cincinnati, Ohio, 45236, United States	Withdrawn
Research Site \| Mentor, Ohio, 44060, United States	Active, not recruiting
Research Site \| Springfield, Ohio, 45503, United States	Withdrawn
Research Site \| Oklahoma City, Oklahoma, 73102, United States	Recruiting
Research Site \| Oklahoma City, Oklahoma, 73112, United States	Active, not recruiting
Research Site \| Oklahoma City, Oklahoma, 73118, United States	Withdrawn
Research Site \| Tulsa, Oklahoma, 74104, United States	Withdrawn
Research Site \| Tulsa, Oklahoma, 74145, United States	Withdrawn
Research Site \| Uniontown, Pennsylvania, 15401, United States	Active, not recruiting
Research Site \| Anderson, South Carolina, 29621, United States	Withdrawn
Research Site \| Greenville, South Carolina, 29615, United States	Withdrawn
Research Site \| Greer, South Carolina, 29650, United States	Withdrawn
Research Site \| Orangeburg, South Carolina, 29118, United States	Not yet recruiting
Research Site \| Johnson City, Tennessee, 37604, United States	Active, not recruiting
Research Site \| Knoxville, Tennessee, 37909, United States	Withdrawn
Research Site \| Amarillo, Texas, 79109, United States	Withdrawn
Research Site \| Austin, Texas, 78726, United States	Withdrawn
Research Site \| Carrollton, Texas, 75007, United States	Completed
Research Site \| Dallas, Texas, 75234, United States	Withdrawn
Research Site \| Houston, Texas, 77017, United States	Active, not recruiting
Research Site \| Houston, Texas, 77030, United States	Not yet recruiting
Research Site \| Houston, Texas, 77030, United States	Withdrawn
Research Site \| Houston, Texas, 77030, United States	Active, not recruiting
Research Site \| Houston, Texas, 77034, United States	Not yet recruiting
Research Site \| Houston, Texas, 77044, United States	Withdrawn
Research Site \| Houston, Texas, 77058, United States	Recruiting
Research Site \| McAllen, Texas, 78503, United States	Completed
Research Site \| McKinney, Texas, 75071, United States	Recruiting
Research Site \| Pflugerville, Texas, 78660, United States	Active, not recruiting
Research Site \| San Antonio, Texas, 78229, United States	Recruiting
Research Site \| San Antonio, Texas, 78258, United States	Withdrawn
Research Site \| Spring, Texas, 77386, United States	Active, not recruiting
Research Site \| Spring, Texas, 77386, United States	Withdrawn
Research Site \| Stafford, Texas, 77477, United States	Not yet recruiting
Research Site \| Bountiful, Utah, 84010, United States	Active, not recruiting
Research Site \| Ogden, Utah, 84405, United States	Withdrawn
Research Site \| Salt Lake City, Utah, 84132, United States	Not yet recruiting
Research Site \| North Chesterfield, Virginia, 23236, United States	Completed
Research Site \| Seattle, Washington, 98195, United States	Withdrawn
Research Site \| Spokane, Washington, 99202, United States	Not yet recruiting
Research Site \| Huntington, West Virginia, 25701, United States	Not yet recruiting
Research Site \| Macquarie University, 2109, Australia	Withdrawn
Research Site \| Murdoch, 6150, Australia	Withdrawn
Research Site \| Innsbruck, 6020, Austria	Withdrawn
Research Site \| Ried, 4910, Austria	Withdrawn
Research Site \| Steyr, 4400, Austria	Not yet recruiting
Research Site \| Wels, 4600, Austria	Not yet recruiting
Research Site \| Plovdiv, 4002, Bulgaria	Withdrawn
Research Site \| New Westminster, British Columbia, V3L 3W4, Canada	Not yet recruiting
Research Site \| Barrie, Ontario, L4M 7G1, Canada	Withdrawn
Research Site \| Hamilton, Ontario, L8N 3Z3, Canada	Not yet recruiting
Research Site \| Ottawa, Ontario, K1H 8L6, Canada	Withdrawn
Research Site \| Toronto, Ontario, M3M 0B2, Canada	Withdrawn
Research Site \| Toronto, Ontario, M5T 2S8, Canada	Withdrawn
Research Site \| Vaughan, Ontario, L4L 4Y7, Canada	Recruiting
Research Site \| Chicoutimi, Quebec, G7H 5H6, Canada	Not yet recruiting
Research Site \| Montreal, Quebec, H1M 1B1, Canada	Withdrawn
Research Site \| Beijing, 100032, China	Withdrawn
Research Site \| Beijing, 100034, China	Withdrawn
Research Site \| Chengdu, 610072, China	Withdrawn
Research Site \| Chongqing, 400010, China	Withdrawn
Research Site \| Guangzhou, 510100, China	Withdrawn
Research Site \| Haidian District, 100191, China	Withdrawn
Research Site \| Nanjing, 210029, China	Withdrawn
Research Site \| Shanghai, 200080, China	Withdrawn
Research Site \| Shanghai, CN-200120, China	Withdrawn
Research Site \| Shanghai, China	Withdrawn
Research Site \| Shenzhen, 518053, China	Withdrawn
Research Site \| Shiyan, 442005, China	Withdrawn
Research Site \| Suzhou, 215006, China	Withdrawn
Research Site \| Wuhan, 430060, China	Withdrawn
Research Site \| Wuxi, 214023, China	Withdrawn
Research Site \| Brno, 636 00, Czechia	Withdrawn
Research Site \| Horovice, 268 31, Czechia	Recruiting
Research Site \| Hradec Kralove, 500 12, Czechia	Recruiting
Research Site \| Ostrava, 702 00, Czechia	Recruiting
Research Site \| Praha 2, 120 00, Czechia	Withdrawn
Research Site \| Usti nad Labem, 401 13, Czechia	Not yet recruiting
Research Site \| Amiens Cedex 1, 80054, France	Not yet recruiting
Research Site \| Bayonne, 64100, France	Withdrawn
Research Site \| Clermond Ferrand, 63003, France	Not yet recruiting
Research Site \| Clichy Cedex, 92118, France	Not yet recruiting
Research Site \| Montpellier Cedex 5, 34295, France	Not yet recruiting
Research Site \| Nice, 06200, France	Not yet recruiting
Research Site \| Paris, 75018, France	Not yet recruiting
Research Site \| Reims, 51092, France	Not yet recruiting
Research Site \| Saint Priest en Jarez, 42270, France	Withdrawn
Research Site \| Augsburg, 86156, Germany	Not yet recruiting
Research Site \| Berlin, 10117, Germany	Withdrawn
Research Site \| Berlin, 10825, Germany	Recruiting
Research Site \| Berlin, 12627, Germany	Withdrawn
Research Site \| Bremen, 28177, Germany	Withdrawn
Research Site \| Dessau-Rosslau, 6847, Germany	Withdrawn
Research Site \| Dortmund, 44137, Germany	Withdrawn
Research Site \| Frankfurt, 60313, Germany	Withdrawn
Research Site \| Hamburg, 20251, Germany	Recruiting
Research Site \| Hamburg, 22297, Germany	Withdrawn
Research Site \| Hannover, 30459, Germany	Withdrawn
Research Site \| Kiel, 24105, Germany	Recruiting
Research Site \| Leipzig, 04103, Germany	Withdrawn
Research Site \| Minden, 32423, Germany	Recruiting
Research Site \| Munich, 80331, Germany	Withdrawn
Research Site \| Neuruppin, 16816, Germany	Withdrawn
Research Site \| Remscheid, 42859, Germany	Recruiting
Research Site \| Ulm, 89081, Germany	Recruiting
Research Site \| Weiden In Der Oberpfalz, 92637, Germany	Withdrawn
Research Site \| Budapest, 1033, Hungary	Suspended
Research Site \| Budapest, 1082, Hungary	Not yet recruiting
Research Site \| Debrecen, 4032, Hungary	Not yet recruiting
Research Site \| Gyöngyös, 3200, Hungary	Withdrawn
Research Site \| Kecskemét, 6000, Hungary	Not yet recruiting
Research Site \| Szeged, 6725, Hungary	Withdrawn
Research Site \| Szekszárd, 7100, Hungary	Withdrawn
Research Site \| Ahemdabad, 380054, India	Withdrawn
Research Site \| Ahemdabad, 380054, India	Not yet recruiting
Research Site \| Ahmedabad, 380006, India	Withdrawn
Research Site \| Ahmedabad, 380052, India	Withdrawn
Research Site \| Assam, 781006, India	Withdrawn
Research Site \| Bangalore, 560054, India	Withdrawn
Research Site \| Bangalore, 560054, India	Not yet recruiting
Research Site \| Gandhinagar, 382428, India	Withdrawn
Research Site \| Hyderabad, 500032, India	Withdrawn
Research Site \| Hyderabad, 500032, India	Not yet recruiting
Research Site \| Hyderabad, 500058, India	Withdrawn
Research Site \| Jaipur, 302001, India	Withdrawn
Research Site \| Jaipur, 302001, India	Not yet recruiting
Research Site \| Jaipur, 302004, India	Withdrawn
Research Site \| Kolkatta, 700026, India	Withdrawn
Research Site \| Nagpur, 440010, India	Withdrawn
Research Site \| New Dehli, 110029, India	Withdrawn
Research Site \| New Delhi, 110017, India	Withdrawn
Research Site \| New Delhi, 110017, India	Not yet recruiting
Research Site \| New Delhi, 110075, India	Withdrawn
Research Site \| New Delhi, 110075, India	Not yet recruiting
Research Site \| Pune, 411001, India	Withdrawn
Research Site \| Rajkot, 360004, India	Withdrawn
Research Site \| Rajkot, 360004, India	Not yet recruiting
Research Site \| Secunderabad, 500003, India	Withdrawn
Research Site \| Secunderabad, 500003, India	Not yet recruiting
Research Site \| Surat, 395002, India	Withdrawn
Research Site \| Surat, 395002, India	Not yet recruiting
Research Site \| Wardha, 442004, India	Withdrawn
Research Site \| Wardha, 442004, India	Not yet recruiting
Research Site \| Haifa, 31048, Israel	Withdrawn
Research Site \| Haifa, 3109601, Israel	Withdrawn
Research Site \| HaIFA, 3109601, Israel	Not yet recruiting
Research Site \| Jerusalem, 9103102, Israel	Not yet recruiting
Research Site \| Jerusalem, 9362410, Israel	Withdrawn
Research Site \| Kfar Saba, 44218, Israel	Not yet recruiting
Research Site \| Nazareth, 16100, Israel	Not yet recruiting
Research Site \| Petah Tikva, 4941492, Israel	Not yet recruiting
Research Site \| Ramat Gan, 52621, Israel	Withdrawn
Research Site \| Rehovot, 76100, Israel	Withdrawn
Research Site \| Tel Aviv, 0, Israel	Withdrawn
Research Site \| Belluno, 32100, Italy	Not yet recruiting
Research Site \| Bologna, 40138, Italy	Not yet recruiting
Research Site \| Caltanissetta, 93100, Italy	Withdrawn
Research Site \| Caserta, 81100, Italy	Withdrawn
Research Site \| Castellana Grotte, 70013, Italy	Not yet recruiting
Research Site \| Chieti, 66100, Italy	Withdrawn
Research Site \| Firenze, 50134, Italy	Not yet recruiting
Research Site \| Foggia, 71100, Italy	Withdrawn
Research Site \| Garbagnate Milanese, 20024, Italy	Not yet recruiting
Research Site \| L Aquila, 67100, Italy	Not yet recruiting
Research Site \| Milano, 20132, Italy	Not yet recruiting
Research Site \| Milano, 20154, Italy	Not yet recruiting
Research Site \| Naples, 80138, Italy	Withdrawn
Research Site \| Napoli, 80131, Italy	Not yet recruiting
Research Site \| Padova, 35128, Italy	Not yet recruiting
Research Site \| Palermo, 90127, Italy	Not yet recruiting
Research Site \| Pavia, 27100, Italy	Not yet recruiting
Research Site \| Roma, 00157, Italy	Not yet recruiting
Research Site \| Roma, 00168, Italy	Withdrawn
Research Site \| Rozzano, 20089, Italy	Not yet recruiting
Research Site \| Salerno, 84131, Italy	Withdrawn
Research Site \| Busan, 48108, Korea, Republic of	Recruiting
Research Site \| Daegu, 38541, Korea, Republic of	Recruiting
Research Site \| Seoul, 03181, Korea, Republic of	Withdrawn
Research Site \| Seoul, 03722, Korea, Republic of	Not yet recruiting
Research Site \| Seoul, 06351, Korea, Republic of	Recruiting
Research Site \| Seoul, 06591, Korea, Republic of	Recruiting
Research Site \| Seoul, 06973, Korea, Republic of	Recruiting
Research Site \| Wonju-si, 26426, Korea, Republic of	Recruiting
Research Site \| Białystok, 15-276, Poland	Not yet recruiting
Research Site \| Bydgoszcz, 85 168, Poland	Not yet recruiting
Research Site \| Bydgoszcz, 85-079, Poland	Recruiting
Research Site \| Bydgoszcz, 85-079, Poland	Not yet recruiting
Research Site \| Chojnice, 89-600, Poland	Not yet recruiting
Research Site \| Częstochowa, 42-202, Poland	Withdrawn
Research Site \| Gdańsk, 80-382, Poland	Withdrawn
Research Site \| Katowice, 40-752, Poland	Withdrawn
Research Site \| Kielce, 25-355, Poland	Recruiting
Research Site \| Końskie, 26-200, Poland	Withdrawn
Research Site \| Krakow, 31-501, Poland	Withdrawn
Research Site \| Kraków, 31-513, Poland	Recruiting
Research Site \| Mysłowice, 41-400, Poland	Withdrawn
Research Site \| Nowa Sól, 67-100, Poland	Withdrawn
Research Site \| Nowy Targ, 34-400, Poland	Withdrawn
Research Site \| Poznan, 60-529, Poland	Withdrawn
Research Site \| Poznań, 60-702, Poland	Withdrawn
Research Site \| Pruszków, 05-800, Poland	Withdrawn
Research Site \| Rzeszow, 35-302, Poland	Recruiting
Research Site \| Rzeszow, 35-302, Poland	Not yet recruiting
Research Site \| Sopot, 81-756, Poland	Not yet recruiting
Research Site \| Szczecin, 71-434, Poland	Withdrawn
Research Site \| Toruń, 87-100, Poland	Not yet recruiting
Research Site \| Warszawa, 00-635, Poland	Not yet recruiting
Research Site \| Warszawa, 02-507, Poland	Not yet recruiting
Research Site \| Warszawa, 03-580, Poland	Not yet recruiting
Research Site \| Wroclaw, 51-162, Poland	Withdrawn
Research Site \| Wroclaw, 51-685, Poland	Withdrawn
Research Site \| Wrocław, 50-449, Poland	Withdrawn
Research Site \| Wrocław, 52-210, Poland	Not yet recruiting
Research Site \| Łódź, 90-302, Poland	Withdrawn
Research Site \| Łódź, 93-338, Poland	Withdrawn
Research Site \| San Juan, 00927, Puerto Rico	Recruiting
Research Site \| Aramil, 624002, Russian Federation	Recruiting
Research Site \| Izhevsk, 426035, Russian Federation	Not yet recruiting
Research Site \| Izhevsk, 426035, Russian Federation	Recruiting
Research Site \| Kazan, 420008, Russian Federation	Not yet recruiting
Research Site \| Kemerovo, 650000, Russian Federation	Not yet recruiting
Research Site \| Krasnodar, 350072, Russian Federation	Not yet recruiting
Research Site \| Moscow, 115419, Russian Federation	Recruiting
Research Site \| Novosibirsk, 630007, Russian Federation	Not yet recruiting
Research Site \| Perm, 614000, Russian Federation	Recruiting
Research Site \| Pyatigorsk, 357500, Russian Federation	Withdrawn
Research Site \| Saint-Petersburg, 195257, Russian Federation	Not yet recruiting
Research Site \| Saint-Petersburg, 196143, Russian Federation	Not yet recruiting
Research Site \| Tomsk, 634050, Russian Federation	Not yet recruiting
Research Site \| Velikiy Novgorod, 173008, Russian Federation	Withdrawn
Research Site \| Banska Bystrica, 97401, Slovakia	Not yet recruiting
Research Site \| Banska Bystrica, 97405, Slovakia	Withdrawn
Research Site \| Bratislava, 81108, Slovakia	Not yet recruiting
Research Site \| Bratislava, 82007, Slovakia	Withdrawn
Research Site \| Bratislava, 83103, Slovakia	Withdrawn
Research Site \| Bratislava, 851 07, Slovakia	Not yet recruiting
Research Site \| Kosice, 04013, Slovakia	Not yet recruiting
Research Site \| Nitra, 94901, Slovakia	Not yet recruiting
Research Site \| Presov, 08001, Slovakia	Withdrawn
Research Site \| Bloemfontein, 9301, South Africa	Not yet recruiting
Research Site \| Bloemfontein, 9301, South Africa	Withdrawn
Research Site \| Cape Town, 1730, South Africa	Withdrawn
Research Site \| Cape Town, 7500, South Africa	Recruiting
Research Site \| Cape Town, 7708, South Africa	Withdrawn
Research Site \| Johannesburg, 1827, South Africa	Withdrawn
Research Site \| Johannesburg, 1827, South Africa	Not yet recruiting
Research Site \| Johannesburg, 2193, South Africa	Withdrawn
Research Site \| Plumstead, 7800, South Africa	Withdrawn
Research Site \| Plumstead, 7800, South Africa	Not yet recruiting
Research Site \| Plumstead, 7800, South Africa	Recruiting
Research Site \| Port Elizabeth, 6001, South Africa	Withdrawn
Research Site \| Pretoria, 0002, South Africa	Not yet recruiting
Research Site \| Madrid, 28046, Spain	Not yet recruiting
Research Site \| Madrid, 28046, Spain	Recruiting
Research Site \| Pamplona, 31008, Spain	Recruiting
Research Site \| Pontevedra, 36071, Spain	Recruiting
Research Site \| Sevilla, 41013, Spain	Withdrawn
Research Site \| Sevilla, 41071, Spain	Not yet recruiting
Research Site \| Sevilla, 41071, Spain	Recruiting
Research Site \| Tomelloso, 13700, Spain	Recruiting
Research Site \| Valencia, 46010, Spain	Recruiting
Research Site \| Kaohsiung, 80756, Taiwan	Recruiting
Research Site \| Taichung, 40201, Taiwan	Recruiting
Research Site \| Taichung, 40447, Taiwan	Recruiting
Research Site \| Taipei City, 114, Taiwan	Recruiting
Research Site \| Taipei, 100, Taiwan	Recruiting
Research Site \| Taipei, 11217, Taiwan	Recruiting
Research Site \| Dnipro, 49000, Ukraine	Withdrawn
Research Site \| Ivano-Frankivsk, Ukraine	Withdrawn
Research Site \| Kharkiv Region, 61037, Ukraine	Recruiting
Research Site \| Kherson, 73000, Ukraine	Not yet recruiting
Research Site \| Kyiv, 01023, Ukraine	Not yet recruiting
Research Site \| Kyiv, 01030, Ukraine	Withdrawn
Research Site \| Kyiv, 01033, Ukraine	Withdrawn
Research Site \| Kyiv, 02002, Ukraine	Withdrawn
Research Site \| Kyiv, 02132, Ukraine	Withdrawn
Research Site \| Kyiv, 03037, Ukraine	Withdrawn
Research Site \| Kyiv, 03680, Ukraine	Recruiting
Research Site \| Kyiv, 03680, Ukraine	Not yet recruiting
Research Site \| Kyiv, 04050, Ukraine	Not yet recruiting
Research Site \| Kyiv, 04050, Ukraine	Recruiting
Research Site \| Kyiv, 04078, Ukraine	Recruiting
Research Site \| Kyiv, 1049, Ukraine	Withdrawn
Research Site \| Kyiv, 4107, Ukraine	Withdrawn
Research Site \| Lviv, 79059, Ukraine	Not yet recruiting
Research Site \| Odesa, 65114, Ukraine	Withdrawn
Research Site \| Poltava, 36011, Ukraine	Withdrawn
Research Site \| Ternopil, 46001, Ukraine	Not yet recruiting
Research Site \| Uzhhorod, 88018, Ukraine	Not yet recruiting
Research Site \| Vinnytsia, 21001, Ukraine	Withdrawn
Research Site \| Vinnytsia, 21009, Ukraine	Recruiting
Research Site \| Vinnytsia, 21009, Ukraine	Not yet recruiting
Research Site \| Vinnytsya, 21028, Ukraine	Not yet recruiting
Research Site \| Zaporizhzhia, 69600, Ukraine	Withdrawn
Research Site \| Cardiff, CF14 5GJ, United Kingdom	Withdrawn
Research Site \| Chorley, PR7 7NA, United Kingdom	Withdrawn
Research Site \| Coventry, CV2 2DX, United Kingdom	Suspended
Research Site \| Edgbaston, B15 2SQ, United Kingdom	Withdrawn
Research Site \| Epsom, KT18 7EG, United Kingdom	Withdrawn
Research Site \| Glasgow, G20 OSP, United Kingdom	Withdrawn
Research Site \| Hexham, NE46 1QJ, United Kingdom	Withdrawn
Research Site \| Liverpool, L22 0LG, United Kingdom	Withdrawn
Research Site \| Manchester, M15 6SX, United Kingdom	Withdrawn
Research Site \| Nottingham, NG7 2UH, United Kingdom	Suspended
Research Site \| Reading, RG2 0TG, United Kingdom	Withdrawn
Research Site \| Stockton, TS19 8PE, United Kingdom	Withdrawn
Research Site \| West Bromwich, B71 4HJ, United Kingdom	Suspended

Расположение Страны	Australia Austria Bulgaria Canada China Czechia France Germany Hungary India Israel Italy Korea, Republic of Poland Puerto Rico Russian Federation Slovakia South Africa Spain Taiwan Ukraine United Kingdom United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Crohn Disease
Количество рук	6
Группа вооружений	Метка: (Stage 1) Brazikumab high dose Тип: Experimental Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Метка: (Stage 1) Brazikumab low dose Тип: Experimental Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Метка: (Stage 1) Placebo Тип: Placebo Comparator Описание: Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48 Метка: (Stage 2) Brazikumab high dose Тип: Experimental Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Метка: (Stage 2) Brazikumab low dose Тип: Experimental Описание: Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48 Метка: (Stage 2) Humira® Тип: Active Comparator Описание: Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
Акроним	INTREPID
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Triple (Participant, Care Provider, Investigator)

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn