A Study to Evaluate Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Not Applicable
Not yet recruiting
- Conditions
- Primary Membranous Nephropathy
- Interventions
- Registration Number
- NCT07204275
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
• Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility
Key
Exclusion Criteria
• Hypersensitivity to investigational medicinal product or to any of its excipients
Other protocol defined Inclusion/Exclusion criteria will apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 2b: Povetacicept Povetacicept Participants will be randomized to receive one of the two doses of Povetacicept. Phase 3: Povetacicept Povetacicept Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). Phase 3: Calcineurin Inhibitor (CNI) Tacrolimus Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
- Primary Outcome Measures
Name Time Method Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) At Week 104
- Secondary Outcome Measures
Name Time Method Proportion of Participants with Complete Clinical Remission Definition 2 (CR2) At Week 104 Proportion of Participants with Overall Clinical Remission (OR) At Week 104