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NCT Number: NCT07204275

Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)

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

Recruiting

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Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Monash Medical Centre, Clayton, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povetacicept

Drug

Solution for Subcutaneous Injection.

Tacrolimus

Drug

Capsules for Oral Administration.

Primary outcomes

  1. Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)

    Time frame: At Week 104

Secondary outcomes

  1. Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)

    Time frame: At Week 104

  2. Proportion of Participants with Overall Clinical Remission (OR)

    Time frame: At Week 104

  3. Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Week 112

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

001-617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Collaborators

  • Zai Lab (Shanghai) Co., Ltd. (for China only)

Registry information

Official study title

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

Acronym: OLYMPUS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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