Primary Membranous Nephropathy
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Interventions
DRUGPovetacicept
Solution for Subcutaneous Injection.
DRUGTacrolimus
Capsules for Oral Administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Zai Lab (Shanghai) Co., Ltd. (for China only)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) | At Week 104 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants with Complete Clinical Remission Definition 2 (CR2) | At Week 104 |
| Proportion of Participants with Overall Clinical Remission (OR) | At Week 104 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Week 112 |
Countries
Australia, Brazil, China, Czechia, Germany, Hungary, Ireland, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTMedical Information
Outcome results
None listed