Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
OLYMPUS
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
2 other identifiers
interventional
176
13 countries
86
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2025
Typical duration for phase_2
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
April 24, 2026
April 1, 2026
3.2 years
September 24, 2025
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
At Week 104
Secondary Outcomes (3)
Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)
At Week 104
Proportion of Participants with Overall Clinical Remission (OR)
At Week 104
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Week 112
Study Arms (3)
Phase 2b: Povetacicept
EXPERIMENTALParticipants will be randomized to receive one of the two doses of Povetacicept.
Phase 3: Povetacicept
EXPERIMENTALParticipants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b).
Phase 3: Calcineurin Inhibitor (CNI)
ACTIVE COMPARATORParticipants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to investigational medicinal product or to any of its excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Renal Associates
Montgomery, Alabama, 36117, United States
Southwest Kidney Institute, PLC (SKI) - Surprise
Surprise, Arizona, 85374, United States
Academic Medical Research Institute (AMRI)
Los Angeles, California, 90022, United States
Valiance Clinical Research - Internal Medicine
Tarzana, California, 91356, United States
Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, 80002, United States
Bioresearch Partner
Miami, Florida, 33127, United States
CTR Oakwater, LLC
Orlando, Florida, 32806, United States
Clinical Site Partners, LLC - Orlando
Winter Park, Florida, 32789, United States
DaVita Clinical Research Columbus
Columbus, Georgia, 31904, United States
Georgia Nephrology
Lawrenceville, Georgia, 30046, United States
CARE Institute-Boise Kidney
Boise, Idaho, 83706, United States
NANI Research
Hinsdale, Illinois, 60521, United States
DaVita Clinical Research Edina
Edina, Minnesota, 55435, United States
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89107, United States
Carolina Nephrology Greenville
Greenville, South Carolina, 29605, United States
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306, United States
El Paso Kidney Specialists
El Paso, Texas, 79902, United States
Provecta Research Network
Houston, Texas, 77027, United States
DaVita Clinical Research Houston
Houston, Texas, 77054, United States
Davita Clinical Research San Antonio
San Antonio, Texas, 78251, United States
Utah Kidney Research
Salt Lake City, Utah, 84115, United States
Milwaukee Neprologists, SC
Wauwatosa, Wisconsin, 53226, United States
St George Private Hospital
Kogarah, Australia
University of Newcastle - John Hunter Hospital (JHH)
New Lambton Heights, Australia
Santa Casa de Misericordia
Porto Alegre, Brazil
Fundação Bahiana de Infectologia
Salvador, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
São Paulo, Brazil
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
The Second Norman Bethune Hospital of Jilin University
Changchun, China
Xiangya Hospital of Central South University
Changsha, China
Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
Chengdu, China
Dalian Municipal Central Hospital
Dalian, China
Dongguan People's Hospital
Dongguan, China
Fuyang People's Hospital
Fuyang, China
Guangdong Provincial People's Hospital
Guangzhou, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
Huai'an, China
The Second Qilu Hospital of Shandong University
Jinan, China
Liu Zhou Works Hospital
Liuchow, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Nanyang Central Hospital
Nanyang, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai General Hospital
Shanghai, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Tai'an City Central Hosptial
Tai’an, China
Weifang People's Hospital
Weifang, China
Wuxi People's Hospital
Wuxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Yantai YuHuangDing Hospital
Yantai, China
Yichang Central People Hospital
Yichang, China
Vseobecna fakultni nemocnice v Praze - Klinika nefrologie
Prague, Czechia
Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl
Allemagne, Germany
Klinikum St. Georg gGmbH - Nephrology
Leipzig, Germany
Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
Leipzig, Germany
Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
Würzburg, Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
Beaumont Hospital
Dublin, Ireland
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Fondazione Salvatore Maugeri - Nefrologia e Dialisi
Pavia, Italy
Kanazawa University Hospital
Kanazawa, Japan
Kasugai Municipal Hospital
Kasugai, Japan
The University of Osaka Hospital
Suita, Japan
Fujita Health University
Toyoake-Shi, Japan
Hallym University Sacred Heart Hospital
Anyang-si, South Korea
Korea University Anam Hospital - Nephrology
Seoul, South Korea
Kyung Hee University Hospital at Gangdong - Nephrology
Seoul, South Korea
Samsung Medical Center - Nephrology
Seoul, South Korea
Severance Hospital, Yonsei University Health System - Nephrology
Seoul, South Korea
Yongin Severance Hospital - Nephrology
Yongin-si, South Korea
Hospital Universitari Vall D Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Ribera Polusa
Lugo, Spain
Clinica Universidad de Navarra - Nefrología
Pamplona, Spain
Hospital Universitario Virgen de la Macarena - Nefrología
Seville, Spain
University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby, United Kingdom
Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
Doncaster, United Kingdom
NHS Lothian - Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
London, United Kingdom
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
October 2, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
December 29, 2028
Study Completion (Estimated)
December 29, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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/