A Study to Evaluate Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) (OLYMPUS)

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Primary Membranous Nephropathy

Treatments: Drug: Tacrolimus; Drug: Povetacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT07204275

VX24-AIS-D10

2025-521661-27-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria will apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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176 participants in 3 patient groups

Phase 2b: Povetacicept

Experimental group

Description:

Participants will be randomized to receive one of the two doses of Povetacicept.

Treatment:

Drug: Povetacicept

Phase 3: Povetacicept

Experimental group

Description:

Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).

Treatment:

Drug: Povetacicept

Phase 3: Calcineurin Inhibitor (CNI)

Active Comparator group

Description:

Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.

Treatment:

Drug: Tacrolimus