A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease (NCT06531395) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
Stopped: Terminated due to strategic business decision.
United States3 participantsStarted 2024-07-17
Plain-language summary
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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), includin…
What they're measuring
1
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24