| Спонсоры |
Ведущий спонсор: Sanofi |
|---|---|
| Источник | Sanofi |
| Краткое содержание | Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: - To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures - To evaluate the safety and tolerability of SAR441344 - To evaluate pharmacokinetics of SAR441344 |
| Подробное описание | The duration of each participant will be no longer than 116 weeks in both parts of the study, including 4 weeks of screening, at maximum 88 weeks of treatment and 24 weeks of follow-up. |
||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Общий статус | Recruiting | ||||||||||||||||||
| Дата начала | 2021-06-07 | ||||||||||||||||||
| Дата завершения | 2023-12-01 | ||||||||||||||||||
| Дата первичного завершения | 2022-05-01 | ||||||||||||||||||
| Фаза | Phase 2 | ||||||||||||||||||
| Тип исследования | Interventional | ||||||||||||||||||
| Первичный результат |
|
||||||||||||||||||
| Вторичный результат |
|
||||||||||||||||||
| Регистрация | 120 |
| Состояние |
|
|---|---|
| Вмешательство |
Тип вмешательства: Drug Название вмешательства: SAR441344 IV Описание: Pharmaceutical form: Solution Route of administration: IV infusion Этикетка Arm Group: IV SAR441344 Тип вмешательства: Drug Название вмешательства: placebo IV Описание: Pharmaceutical form: Solution Route of administration: IV infusion Этикетка Arm Group: IV Placebo Тип вмешательства: Drug Название вмешательства: SAR441344 SC Описание: Pharmaceutical form: Solution Route of administration: SC injection Этикетка Arm Group: SC SAR441344 Тип вмешательства: Drug Название вмешательства: placebo SC Описание: Pharmaceutical form: Solution Route of administration: SC injection Этикетка Arm Group: SC Placebo Тип вмешательства: Drug Название вмешательства: MRI contrast-enhancing preparations Описание: Pharmaceutical form: Solution Route of administration: IV injection |
| Приемлемость |
Критерии: Inclusion criteria: - Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. - The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria. - The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening. - Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening. - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Capable of giving signed informed consent. Exclusion criteria: - The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS. - The participant has conditions or situations that would adversely affect participation in this study. - The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study. - History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment. - Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule. - The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment. - The participant has taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit. - The participant has an EDSS score >5.5 at the first screening visit. - The participant has had a relapse in the 30 days prior to randomization. - Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission. - Abnormal laboratory test(s) at Screening. - Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention. - Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Пол: All Минимальный возраст: 18 Years Максимальный возраст: 55 Years Здоровые волонтеры: No |
| Общий Официальный |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Общий контакт |
Фамилия: Trial Transparency email recommended (Toll free number for US & Canada) Телефон: 800-633-1610 Телефон доб.: option 6 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Расположение |
|
| Расположение Страны |
Bulgaria Canada Czechia France Germany Spain Turkey Ukraine United States |
|---|---|
| Дата проверки |
2021-11-25 |
| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр |
|
| Количество рук | 4 |
| Группа вооружений |
Метка: IV SAR441344 Тип: Experimental Описание: SAR441344 IV Метка: IV Placebo Тип: Placebo Comparator Описание: Placebo IV Метка: SC SAR441344 Тип: Experimental Описание: SAR441344 SC Метка: SC Placebo Тип: Placebo Comparator Описание: Placebo SC |
| Данные пациента | Yes |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Описание модели вмешательства: Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part. Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |