Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Ведущий спонсор: AstraZeneca

Коллаборационист: Iqvia Pty Ltd

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age. Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52.

• Systemic Lupus Erythematosus

Тип вмешательства: Drug

Название вмешательства: Medi-546

Описание: Patients will have IP administered or will self-administer IP under supervision by site staff at Weeks 0, 1, and 2. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration, as follows: - W0 and W1 - 1 kit to be administered at clinic - W2 - 3 kits (1 to be administered at clinic, 2 to be taken home) - W4 - W48 (every 4 weeks) - 5 kits (1 to be administered at clinic, 4 to be taken home) Patients will have approximately 65 kits (including back-up kits) dispensed to them over the course of the 52-week treatment period

Этикетка Arm Group: Anifrolumab

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Solution for injection in aPFS

Этикетка Arm Group: Placebo

Критерии:

Inclusion Criteria: Inclusion CriteriaErythematosus 1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF 2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening 3. BILAG2004 with at least 1 of the following: 1. BILAG2004 level A disease in ≥ 1 organ system 2. BILAG2004 level B disease in ≥ 2 organ systems 4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening 5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening, 6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations. Exclusion Criteria: 7. Active severe or unstable neuropsychiatric SLE 8. Active severe SLE-driven renal disease 9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF. 10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks). 11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening. 12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody 13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1), 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization. 15. History of cancer, apart from: 1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1) 2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

70 Years

Здоровые волонтеры:

No

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Argentina

Bulgaria

Chile

Colombia

Germany

Hungary

Japan

Mexico

Peru

Poland

Russian Federation

Spain

Ukraine

United Kingdom

United States

2021-12-01

Тип: Sponsor

• Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous

• Lupus Erythematosus, Systemic

Метка: Anifrolumab

Тип: Experimental

Описание: Solution for injection in aPFS

Метка: Placebo

Тип: Placebo Comparator

Описание: Solution for injection in aPFS

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Single (Participant)

Описание маскировки: Double Blind (Participant, Care Provider and Investigator)