A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Sjögrens Disease
In brief
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Key facts
- Study ID
- NCT06531395
- Run by
- Kiniksa Pharmaceuticals International, plc
- People needed
- 3
- Starts
- 2024-07-17
- Expected to finish
- 2025-05-01
- Last updated by the study team
- 2025-05-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has a diagnosis of Sjögren's Disease according to 2016 American College or Rheumatology (ACR)-EULAR Classification Criteria.
- Has ESSDAI value ≥ 5, counting only the biological, hematological, articular, cutaneous, glandular, lymphadenopathy, and constitutional organ domains at Screening.
- Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory.
- Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min
- Weighs at least 40 kg and no more than 150 kg and has a body mass index (BMI) within the range of 18-40 kg/m2.
You may not qualify if…
- Prior exposure to any other anti-CD40/CD154 agent.
- Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness, including fibromyalgia with currently active, inadequately controlled symptoms.
- Has received cataract surgery, Lasik, or other ophthalmologic surgery procedure (e.g., lachrymal plug) in the 6 months prior to Screening.
- Injectable corticosteroids (including intra-articular) within 8 weeks prior to randomization.
- Has started, stopped or adjusted dose/regimen of medications for treatment of, or known to cause dry mouth/eyes within the 30 days prior to screening or is anticipating change to these treatment regimens during the study.
- Has history of immunodeficiency (e.g., immune disorders or disorders that result in decreased immunity), including human immunodeficiency virus (HIV).
- History of thromboembolic event or a significant risk of future thromboembolic events.
- Has a known high risk of infection; Has a history of chronic or recurrent infectious disease; Has any known or suspected active infection, or has had a serious infection requiring hospitalization, or has been treated with IV/IM antibiotics for an infection within 8 weeks prior to first dose of study drug or treatment with oral antibiotics for an infection within 2 weeks prior to first dose of study drug.
Where it is running
- Medvin Clinical Research — Menifee, California, United States
- BioSolutions Clinical Research Center — Poway, California, United States
- Medvin Clinical Research — Whittier, California, United States
- International Medical Research — Daytona Beach, Florida, United States
- Omega Research Debary, LLC — DeBary, Florida, United States
- Greater Chicago Specialty Physicians/ Clinical Investigation Specialists — Schaumburg, Illinois, United States
- Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc. — Skokie, Illinois, United States
- Springfield Clinic Rheumatology — Springfield, Illinois, United States
- Accurate Clinical Research, Inc — Lake Charles, Louisiana, United States
- Accellacare (Salisbury) — Salisbury, North Carolina, United States
- Carolina Arthritis Associates — Wilmington, North Carolina, United States
- Arthritis and Rheumatology Research Institute, PLLC — Allen, Texas, United States
- Arthritis Care of Texas — Corpus Christi, Texas, United States
- Trinity Universal Research Associates, Inc. — Plano, Texas, United States
- Sun Research Institute — San Antonio, Texas, United States
- Arthritis & Osteoporosis Clinic — Waco, Texas, United States
Full record on ClinicalTrials.gov
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