A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects With Moderately to Severely Active Primary Sjogren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
研究概览
简要总结
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. In addition, a variety of systemic manifestations may occur; including fatigue, musculoskeletal symptoms, rashes, and internal organ (e.g., pulmonary, renal, hepatic, and neurologic) disease. Sjogren's syndrome may occur in isolation, primary Sjogren's syndrome (pSS), or in a secondary form, often associated with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or systemic sclerosis. Ravagalimab is an investigational drug being developed to help treat patients with inflammatory diseases like SS. This study will evaluate how well ravagalimab works within the body and how safe it is in patients with primary SS (pSS).
Ravagalimab, a potent CD40 antagonist is an investigational drug being developed for the treatment of Sjogren's syndrome (SS). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Participants 18-75 years of age with Sjogren's syndrome (SS) will be enrolled. Around 45 participants will be enrolled in the study in multiple sites within Netherlands.
Participants will receive ravagalimab intravenous (IV) loading dose or IV placebo at baseline followed by subcutaneous (SC) ravagalimab or matching placebo for 22 weeks.
There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, labial gland (lip) biopsy, and checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Sjogren's syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 Criteria.
- •Lymphocyte focus score (local lymphocytic infiltrates) >= 1 in sublabial salivary gland specimen. Subjects with sublabial salivary gland biopsy obtained 3 months prior to Screening and meeting this criterion will be eligible without a biopsy at Screening. Subjects without a sublabial salivary gland biopsy within 3 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
- •EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 at Screening.
- •EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 6 at Screening.
排除标准
- •History of clinically significant drug or alcohol abuse within the last 6 months.
- •History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients), the ingredients of Chinese hamster ovary cells and/or other products in the same class.
研究组 & 干预措施
Ravagalimab
Participants will receive a loading dose of intravenous (IV) ravagalimab dose A at Week 0 followed by subcutaneous (SC) ravagalimab dose A every other week (eow)
干预措施: Ravaglimab (Drug)
Ravagalimab
Participants will receive a loading dose of intravenous (IV) ravagalimab dose A at Week 0 followed by subcutaneous (SC) ravagalimab dose A every other week (eow)
干预措施: Ravagalimab (Drug)
Placebo
Participants will receive a loading dose of intravenous (IV) placebo at Week 0 followed by subcutaneous (SC) placebo every other week (eow)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
时间窗: Week 24
ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).
次要结局
- Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)(Up to Week 16)
- Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)(Up to Week 24)
- Change From Baseline in Tender Joint Count(Up to Week 24)
- Change From Baseline in Swollen Joint Count(Up to Week 24)
- Change From Baseline in Salivary Flow (Unstimulated)(Up to Week 24)
- Change From Baseline in Salivary Flow (Stimulated)(Up to Week 24)
- Change From Baseline in Lacrimal Flow (Schirmer's Test of Ocular Function)(Up to Week 24)
- Change From Baseline in Van Bijsterveld Score(Up to Week 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(Up to Week 24)
- Change From Baseline in Patient's Global Assessment of Disease Activity Numeric Rating Scales(Up to Week 24)
- Change From Baseline in Physician's Global Assessment of Disease Activity Numeric Rating Scales(Up to Week 24)
- Change from Baseline in anti-Sjogrens-syndrome-related antigen A (anti-SSA)(Up to Week 24)
- Change from Baseline in anti-Sjogrens-syndrome-related antigen B (anti-SSB)(Up to Week 24)
- Change from Baseline in antinuclear antibody (ANA)(Up to Week 24)
- Change from Baseline in rheumatoid factor (RF)(Up to Week 24)
- Change from Baseline in high-sensitivity C-reactive protein (hsCRP)(Up to Week 24)
- Change from Baseline in immunoglobulin M (IgM)(Up to Week 24)
- Change from Baseline in immunoglobulin M (IgG)(Up to Week 24)
- Change from Baseline in immunoglobulin A (IgA)(Up to Week 24)
- Change from Baseline in Serum-Free Light Chains(Up to Week 24)
- Change from Baseline in Serum C3(Up to Week 24)
- Change from Baseline in Serum C4(Up to Week 24)
- Change from Baseline in Haemolytic Complement CH50(Up to Week 24)
- Change From Baseline in Focus Score of Sublabial Salivary Gland Biopsy (In Participants With a Screening and Week 24 Biopsy)(Week 24)