A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Parti… (NCT06928142) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
United States83 participantsStarted 2025-04-23
Plain-language summary
This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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Key Inclusion Criteria:
* Diagnosed with Sjögren's disease.
* ESSDAI score (which measures disease activity) must be 5 or higher.
* Salivary flow rate must be at least 0.05 mL/min.
* Serum IgG level must be higher than 900 mg/dL.
* Must be able to communicate well with the investigator and agree to follow the trial requirements.
* Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
* Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
* Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
Key Exclusion Criteria:
* Another active autoimmune rheumatic disease.
* Prior use of B-cell depleting therapy or prohibited immunosuppressants.
* Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
* Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).
What they're measuring
1
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) score
Timeframe: 28 weeks
Trial details
NCT IDNCT06928142
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.