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Clinical Trials in the EU / 2025-521661-27-00
Completed Phase III

A Phase 2b/3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy

2025-521661-27-00 · tracked via the Priya Life Science EU tracker
Sponsor
Vertex Pharmaceuticals Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Immune System Diseases
Decision date
12/12/2025
Enrollment target
30
Sites
Hungary, Ireland, Czechia, Italy, Spain, Germany, Netherlands

Condition studied

Primary Membranous Nephropathy

Investigational medicinal product(s)

TACROLIMUSTest IMP without active substanceALPN-303 solution for injectionALPN-303 Solution for Injection in Pre-filled PenTACROLIMUSTACROLIMUS

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Proportion of Participants with Complete Clinical Remission Definition 1 (CR1) CR1 [Time Frame: At Week 72]

Endpoint detail

Proportion of Participants with Complete Clinical Remission Definition 2 (CR2). [Time Frame: At Week 72], Proportion of Participants with Overall Clinical Remission (OR). [Time Frame: At Week 72], Safety and tolerability as determined by AEs, clinical laboratory values, standard 12-lead ECGs, and vital signs

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521661-27-00 on CTIS ↗ ← All trials in the EU