Status:
RECRUITING
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Sjogren Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg adm...
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 4 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06928142
Start Date
April 23 2025
End Date
June 4 2027
Last Update
December 1 2025
Active Locations (72)
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1
Kirk Kerkorian School of Medicine UNLV
Birmingham, Alabama, United States, 35233
2
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Riverside, California, United States, 92508
3
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Tujunga, California, United States, 91042
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