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

June 4, 2026 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Kogarah, Australia
        • Recruiting
        • St George Private Hospital
      • New Lambton Heights, Australia
        • Recruiting
        • University of Newcastle - John Hunter Hospital (JHH)
  • Brazil
      • Belo Horizonte, Brazil
        • Recruiting
        • Freire Pesquisa Clínica
      • Porto Alegre, Brazil
        • Recruiting
        • Santa Casa de Misericordia
      • Recife, Brazil
        • Recruiting
        • Universidade Federal de Pernmabuco
      • Salvador, Brazil
        • Recruiting
        • Fundação Bahiana de Infectologia
      • São Paulo, Brazil
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
  • China
      • Baotou, China
        • Recruiting
        • The First Affiliated Hospital of Baotou Medical College
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
      • Beijing, China
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
      • Changchun, China
        • Recruiting
        • The Second Norman Bethune Hospital of Jilin University
      • Changsha, China
        • Recruiting
        • Xiangya Hospital of Central South University
      • Chengdu, China
        • Recruiting
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
      • Dalian, China
        • Recruiting
        • Dalian Municipal Central Hospital
      • Dongguan, China
        • Recruiting
        • Dongguan People's Hospital
      • Fuyang, China
        • Recruiting
        • Fuyang People's Hospital
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
      • Harbin, China
        • Recruiting
        • The 2nd Affiliated Hospital of Harbin Medical University
      • Huai'an, China
        • Recruiting
        • The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
      • Jinan, China
        • Recruiting
        • The Second Qilu Hospital of Shandong University
      • Liuzhou, China
        • Recruiting
        • Liu Zhou Works Hospital
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanning, China
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
      • Nanyang, China
        • Recruiting
        • Nanyang Central Hospital
      • Ningbo, China
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
      • Shanghai, China
        • Recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
      • Shijiazhuang, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
      • Shijiazhuang, China
        • Recruiting
        • The First Hospital of Hebei Medical University
      • Shijiazhuang, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical Univesrsity
      • Tai’an, China
        • Recruiting
        • Tai'an City Central Hosptial
      • Weifang, China
        • Recruiting
        • Weifang People's Hospital
      • Wuxi, China
        • Recruiting
        • Wuxi People's Hospital
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi 'an Jiaotong University
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
      • Yantai, China
        • Recruiting
        • Yantai Yuhuangding Hospital
      • Yichang, China
        • Recruiting
        • Yichang Central People Hospital
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze - Klinika nefrologie
  • Germany
      • Allemagne, Germany
        • Recruiting
        • Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl
      • Leipzig, Germany
        • Recruiting
        • Klinikum St. Georg gGmbH - Nephrology
      • Leipzig, Germany
        • Recruiting
        • Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
  • Hungary
      • Szeged, Hungary
        • Recruiting
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Beaumont Hospital
      • Dublin, Ireland
        • Recruiting
        • St. Vincent's University Hospital
      • Galway, Ireland
        • Recruiting
        • University Hospital Galway
  • Italy
      • Genova, Italy
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
      • Naples, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
      • Pavia, Italy
        • Recruiting
        • Fondazione Salvatore Maugeri - Nefrologia e Dialisi
  • Japan
      • Kanazawa, Japan
        • Recruiting
        • Kanazawa University Hospital
      • Kasugai, Japan
        • Recruiting
        • Kasugai Municipal Hospital
      • Okayama, Japan
        • Recruiting
        • Okayama University Hospital
      • Shōwaku, Japan
        • Recruiting
        • Nagoya University Hospital
      • Suita, Japan
        • Recruiting
        • The University of Osaka Hospital
      • Toyoake-Shi, Japan
        • Recruiting
        • Fujita Health University
  • South Korea
      • Anyang-si, South Korea
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital - Nephrology
      • Seoul, South Korea
        • Recruiting
        • Kyung Hee University Hospital at Gangdong - Nephrology
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center - Nephrology
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital, Yonsei University Health System - Nephrology
      • Yongin-si, South Korea
        • Recruiting
        • Yongin Severance Hospital - Nephrology
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d Hebron
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
      • Lugo, Spain
        • Recruiting
        • Hospital Ribera Polusa
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra - Nefrología
      • Seville, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Macarena - Nefrología
  • United Kingdom
      • Derby, United Kingdom
        • Recruiting
        • University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
      • Doncaster, United Kingdom
        • Recruiting
        • Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
      • Edinburgh, United Kingdom
        • Recruiting
        • NHS Lothian - Royal Infirmary of Edinburgh
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • London, United Kingdom
        • Recruiting
        • St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
      • Wolverhampton, United Kingdom
        • Recruiting
        • The Royal Wolverhampton NHS Trust - New Cross Hospital
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36117
        • Recruiting
        • Renal Associates
    • Arizona
      • Surprise, Arizona, United States, 85374
        • Recruiting
        • Southwest Kidney Institute, PLC (SKI) - Surprise
    • California
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute (AMRI)
      • Tarzana, California, United States, 91356
        • Recruiting
        • Valiance Clinical Research - Internal Medicine
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Recruiting
        • Western Nephrology & Metabolic Bone Disease PC
    • Florida
      • Miami, Florida, United States, 33127
        • Recruiting
        • BioResearch Partner
      • Orlando, Florida, United States, 32806
        • Recruiting
        • CTR Oakwater, LLC
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Clinical Site Partners, LLC - Orlando
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • DaVita Clinical Research Columbus
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Georgia Nephrology
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • CARE Institute-Boise Kidney
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • NANI Research
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • DaVita Clinical Research Edina
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Recruiting
        • Kidney Specialists of Southern Nevada
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Carolina Nephrology Greenville
      • Spartanburg, South Carolina, United States, 29306
        • Recruiting
        • Carolina Nephrology, PA
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • El Paso Kidney Specialists
      • Houston, Texas, United States, 77027
        • Recruiting
        • Provecta Research Network
      • Houston, Texas, United States, 77054
        • Recruiting
        • DaVita Clinical Research Houston
      • San Antonio, Texas, United States, 78251
        • Recruiting
        • Davita Clinical Research San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84115
        • Recruiting
        • Utah Kidney Research
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Milwaukee Neprologists, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2b: Povetacicept
Participants will be randomized to receive one of the two doses of Povetacicept.
Drug: Povetacicept
Solution for Subcutaneous Injection.
Experimental: Phase 3: Povetacicept
Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).
Drug: Povetacicept
Solution for Subcutaneous Injection.
Active Comparator: Phase 3: Calcineurin Inhibitor (CNI)
Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
Drug: Tacrolimus
Capsules for Oral Administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
Time Frame: At Week 104
At Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)
Time Frame: At Week 104
At Week 104
Proportion of Participants with Overall Clinical Remission (OR)
Time Frame: At Week 104
At Week 104
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
From Day 1 up to Week 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2025

Primary Completion (Estimated)

December 29, 2028

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

September 24, 2025

First Posted (Actual)

October 2, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-AIS-D10
  • 2025-521661-27-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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