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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521661-27-00

Acronym

VX24-AIS-D10

Enrollment

Registered

2025-12-12

Start date

2025-12-19

Completion date

Unknown

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Membranous Nephropathy

Brief summary

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

Detailed description

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

Interventions

DRUGTACROLIMUS

DRUGALPN-303 solution for injection in pre-filled syringe

DRUGALPN-303 solution for injection

DRUGTest IMP without active substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Czechia, Germany, Hungary, Ireland, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026