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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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