Primary Membranous NephropathyPhase 2/3OLYMPUSNCT07204275
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
A Phase 2/3 study testing Povetacicept and Tacrolimus in people with Primary Membranous Nephropathy, run by Vertex Pharmaceuticals Incorporated at 115 sites in 14 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Povetacicept and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 115 sitesin 14 countries
- Study dates
- 30 Sep 2025to 29 Dec 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to investigational medicinal product or to any of its excipients
- Other protocol defined Inclusion/Exclusion criteria will apply
Trial locations and contacts
115 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
115 sites in 14 countries
China34 sites, 33 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
- Recruiting
Peking University First Hospital
Beijing
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
- Recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun
- Recruiting
Xiangya Hospital of Central South University
Changsha
- Recruiting
Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
Chengdu
- Recruiting
Dalian Municipal Central Hospital
Dalian
- Recruiting
Dongguan People's Hospital
Dongguan
- Recruiting
Fuyang People's Hospital
Fuyang
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
- Withdrawn
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin
- Recruiting
The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University
Huai'an
- Recruiting
The Second Qilu Hospital of Shandong University
Jinan
- Recruiting
Liu Zhou Works Hospital
Liuzhou
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
- Recruiting
Nanyang Central Hospital
Nanyang
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
- Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
- Recruiting
Shanghai General Hospital
Shanghai
- Recruiting
Shenjing Hospital of China Medical University
Shenyang
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
The Fourth Hospital of Hebei Medical Univesrsity
Shijiazhuang
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
Tai'an City Central Hosptial
Tai’an
- Recruiting
Weifang People's Hospital
Weifang
- Recruiting
Wuxi People's Hospital
Wuxi
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
- Recruiting
Yantai YuHuangDing Hospital
Yantai
- Recruiting
Yichang Central People Hospital
Yichang
United States27 sites, 27 recruiting
- Recruiting
Western Nephrology & Metabolic Bone Disease PC
Arvada, Colorado, 80002
- Recruiting
CARE Institute-Boise Kidney
Boise, Idaho, 83706
- Recruiting
DaVita Clinical Research Columbus
Columbus, Georgia, 31904
- Recruiting
DaVita Clinical Research Edina
Edina, Minnesota, 55435
- Recruiting
El Paso Kidney Specialists
El Paso, Texas, 79902
- Recruiting
Carolina Nephrology Greenville
Greenville, South Carolina, 29605
- Recruiting
NANI Research
Hinsdale, Illinois, 60521
- Recruiting
Provecta Research Network
Houston, Texas, 77027
- Recruiting
DaVita Clinical Research Houston
Houston, Texas, 77054
- Recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI) - Indianapolis South
Indianapolis, Indiana, 46227
- Recruiting
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89107
- Recruiting
Georgia Nephrology
Lawrenceville, Georgia, 30046
- Recruiting
Academic Medical Research Institute (AMRI)
Los Angeles, California, 90022
- Recruiting
Bioresearch Partner
Miami, Florida, 33127
- Recruiting
Renal Associates
Montgomery, Alabama, 36117
- Recruiting
NYU Medical Center
New York, New York, 10016-9196
- Recruiting
CTR Oakwater, LLC
Orlando, Florida, 32806
- Recruiting
St. Clair Nephrology Research
Roseville, Missouri, 48066
- Recruiting
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
- Recruiting
Utah Kidney Research
Salt Lake City, Utah, 84115
- Recruiting
Davita Clinical Research San Antonio
San Antonio, Texas, 78251
- Recruiting
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, 71101
- Recruiting
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306
- Recruiting
Southwest Kidney Institute, PLC (SKI) - Surprise
Surprise, Arizona, 85374
- Recruiting
Valiance Clinical Research - Internal Medicine
Tarzana, California, 91356
- Recruiting
Milwaukee Neprologists, SC
Wauwatosa, Wisconsin, 53226
- Recruiting
Clinical Site Partners, LLC - Orlando
Winter Park, Florida, 32789
Japan8 sites, 8 recruiting
- Recruiting
Kanazawa University Hospital
Kanazawa
- Recruiting
Kasugai Municipal Hospital
Kasugai
- Recruiting
St.Marianna University School of Medicine Hospital
Kawasaki-shi
- Recruiting
Okayama University Hospital
Okayama
- Recruiting
Nagoya University Hospital
Shōwaku
- Recruiting
The University of Osaka Hospital
Suita
- Recruiting
Fujita Health University
Toyoake-Shi
- Recruiting
Juntendo University Urayasu Hospital
Urayasu
South Korea7 sites, 7 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si
- Recruiting
Korea University Anam Hospital - Nephrology
Seoul
- Recruiting
Korea University Guro Hospital - Nephrology
Seoul
- Recruiting
Kyung Hee University Hospital at Gangdong - Nephrology
Seoul
- Recruiting
Samsung Medical Center - Nephrology
Seoul
- Recruiting
Severance Hospital, Yonsei University Health System - Nephrology
Seoul
- Recruiting
Yongin Severance Hospital - Nephrology
Yongin-si
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall D Hebron
Barcelona
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
- Recruiting
Hospital de Vinalopó
Elche
- Recruiting
Hospital Ribera Polusa
Lugo
- Recruiting
Clinica Universidad de Navarra - Nefrología
Pamplona
- Recruiting
Hospital Universitario Virgen de la Macarena - Nefrología
Seville
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospital of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby
- Recruiting
Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Doncaster Royal Infirmary
Doncaster
- Recruiting
NHS Lothian - Royal Infirmary of Edinburgh
Edinburgh
- Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London
- Recruiting
St George's University Hospitals NHS Foundation Trust - St George's Hospital- Renal Medicine
London
- Recruiting
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton
Brazil5 sites, 5 recruiting
- Recruiting
Freire Pesquisa Clinica
Belo Horizonte
- Recruiting
Santa Casa de Misericordia
Porto Alegre
- Recruiting
Universidade Federal de Pernmabuco
Recife
- Recruiting
Fundação Bahiana de Infectologia
Salvador
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP - HC- FMUSP
São Paulo
Italy5 sites, 5 recruiting
- Recruiting
AOU Consorziale Policlinico di Bari - Nefrologia, Dialisi e Trapianti
Bari
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
- Recruiting
Fondazione Salvatore Maugeri - Nefrologia e Dialisi
Pavia
Australia4 sites, 4 recruiting
- Recruiting
Monash Medical Centre
Clayton
- Recruiting
Concord Repatriation General Hospital
Concord
- Recruiting
St George Private Hospital
Kogarah
- Recruiting
University of Newcastle - John Hunter Hospital (JHH)
New Lambton Heights
Germany4 sites, 4 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin Campus Benjamin Frankl
Allemagne
- Recruiting
Klinikum St. Georg gGmbH - Nephrology
Leipzig
- Recruiting
Universitaetsklinikum Leipzig - Medizinische Klinik und Poliklinik III - Klinik und Poliklinik fuer Endokrinologie, Nephrologie
Leipzig
- Recruiting
Universitaetsklinikum Wuerzburg - Innere Medizin, Nephrologie
Würzburg
Ireland4 sites, 4 recruiting
- Recruiting
Cork University Hospital - Nephrology
Cork
- Recruiting
Beaumont Hospital
Dublin
- Recruiting
St. Vincent'S University Hospital
Dublin
- Recruiting
University Hospital Galway
Galway
Czechia2 sites, 2 recruiting
- Recruiting
FN Kralovske Vinohrady - Interni klinika
Prague
- Recruiting
Vseobecna fakultni nemocnice v Praze - Klinika nefrologie
Prague
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC - Nephrology
Amsterdam
- Recruiting
Radboud universitair medisch centrum / RADBOUDUMC - Nephrology
Nijmegen
Hungary1 site, 1 recruiting
- Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
About this study
Official 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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Povetacicept, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Solution for Subcutaneous Injection.
TacrolimusDrug
Capsules for Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2b: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept. Receives: Drug: Povetacicept |
| Phase 3: Povetacicept | Experimental | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). Receives: Drug: Povetacicept |
| Phase 3: Calcineurin Inhibitor (CNI) | Active comparator | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Complete Clinical Remission Definition 1 (CR1)
Measured: At Week 104
Secondary outcomes (3)
Proportion of Participants with Complete Clinical Remission Definition 2 (CR2)
Measured: At Week 104
Proportion of Participants with Overall Clinical Remission (OR)
Measured: At Week 104
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start30 Sep 2025
- Primary completion29 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (Shanghai) Co., Ltd. (for China only)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204275
- Sponsor's protocol ID
- VX24-AIS-D10
- Other IDs
- 2025-521661-27-00, 2025
- Acronym
- OLYMPUS
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/