Status:
TERMINATED
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
Lead Sponsor:
Kiniksa Pharmaceuticals International, plc
Collaborating Sponsors:
Kiniksa Pharmaceuticals, GmbH
Conditions:
Sjögrens Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Detailed Description
This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06531395
Start Date
July 17 2024
End Date
May 1 2025
Last Update
May 21 2025
Active Locations (16)
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1
Medvin Clinical Research
Menifee, California, United States, 92586
2
BioSolutions Clinical Research Center
Poway, California, United States, 92064
3
Medvin Clinical Research
Whittier, California, United States, 90602
4
International Medical Research
Daytona Beach, Florida, United States, 32117