The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus

Обзор

This study will evaluate the effect and safety of 626 in patients with SLE

Подробное описание

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.

The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.

Вмешательства

• Препарат 626
  626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.
• Препарат 626
  626 subcutaneous (SC) injection.
• Препарат Placebo
  Placebo subcutaneous (SC) injection.

Первичные конечные точки

• Number of participants with Adverse Events [Срок оценки: During the 32- or 36-week study period]

Вторичные конечные точки (2)

• SLE Responder Index (SRI-4) [Срок оценки: During the 20- or 24-week treatment period]
• BILAG-based Combined Lupus Assessment (BICLA) Response [Срок оценки: During the 20- or 24-week treatment period]

Критерии участия

Критерии включения

• Able to understand protocol requirements and sign a written ICF.
• Male or female subjects aged 18-70 years when signing the ICF.
• Body weight between 40 and 90 kg.
• Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
• At screening, meet at least one of the following criteria:

• Anti-nuclear antibody (ANA) titer ≥ 1:80;
• Positive anti-dsDNA antibody..
• Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit .
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Критерии исключения

• Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis.
• Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
• Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• History of cancer.
• Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or protein:creatinine ratio >2.0 g/g.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07185269 · SSGJ-626-SLE-Ib/II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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