Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Phase 2
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- Drug: Sibeprenlimab 400 mg s.c. Q4weeks
- Registration Number
- NCT05248659
- Brief Summary
This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.
- Detailed Description
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.
Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
- eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria
- Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
- Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sibeprenlimab 400 mg s.c. q 4 weeks Sibeprenlimab 400 mg s.c. Q4weeks -
- Primary Outcome Measures
Name Time Method Adverse Events From baseline to the end-of-trial visit in Week 112.
- Secondary Outcome Measures
Name Time Method Time to Progression of Chronic Kidney Disease, as defined in the protocol Over 24 months Proportion of Subjects with Clinical Remission as defined in the protocol At 12 and 24 months Annualized slope of Estimated Glomerular Filtration Rate (eGFR) Over 12 and 24 months Urine protein/creatinine ratio (uPCR) in a 24-hour collection At 12 and 24 months
Trial Locations
- Locations (1)
For additional information regarding sites, contact 844-687-8522
🇺🇸New York, New York, United States