Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Study Overview
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Brief Summary
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This is a phase 2/3 open-label study to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.

Detailed Description
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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. Subjects who have not previously received sibeprenlimab will not be enrolled in this trial.

Official Title
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A Phase 2/3, Multicenter, Open-label Extension Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Conditions
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Immunoglobulin A Nephropathy

Intervention / Treatment
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* Drug: Sibeprenlimab 400 mg s.c. Q4weeks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sibeprenlimab 400 mg s.c. q 4 weeks<br> | Drug: Sibeprenlimab 400 mg s.c. Q4weeks<br>* Sibeprenlimab 400 mg s.c. q 4 weeks<br>* Other names: VIS649;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | From baseline to the end-of-trial visit in Week 112. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of Subjects with Clinical Remission as defined in the protocol |  | At 12 and 24 months | 
| Time to Progression of Chronic Kidney Disease, as defined in the protocol |  | Over 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sibeprenlimab, VIS649, IgAN