ClinicalTrials.gg
RecruitingNCT07204275OLYMPUSUpdated Oct 30, 2026

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

A Phase 2/3 interventional study of Povetacicept and Tacrolimus in Primary Membranous Nephropathy, sponsored by Vertex Pharmaceuticals Incorporated. Recruiting at 117 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Vertex Pharmaceuticals Incorporated · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Updated Oct 30, 20262 sites addedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Primary Membranous Nephropathy
03

In context

Glomerulonephritis, Membranous

144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.

This study's planned enrollment of 176 is above the median of 46 across 105 interventional studies indexed under Glomerulonephritis, Membranous.

Browse Glomerulonephritis, Membranous studies →

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 17 are open to participants now.

Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Diagnosed with pMN with confirmatory historical . If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility

Key Exclusion Criteria:

  • to medicinal product or to any of its

Other protocol defined Inclusion/Exclusion criteria will apply

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    Phase 2b: Povetacicept

    Participants will be randomized to receive one of the two doses of Povetacicept.

    Drug: Povetacicept

  • 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

  • Active comparator
    Phase 3: Calcineurin Inhibitor (CNI)

    Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus.

    Drug: Tacrolimus

Interventions

06

What researchers measure

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

07

Study locations

116 of 117 sites recruiting

Showing the first 100 of 117 sites across 14 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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/

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added
Show 2 added (1 United States, 1 Brazil)
  • Metrolina Nephrology Associates, PA · Gastonia, United States
  • Hospital das Clinicas da Universidade Federal de Goias · Goiânia, Brazil
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    2 sites added
    Show 2 added (1 United States, 1 Brazil)
    • Metrolina Nephrology Associates, PA · Gastonia, United States
    • Hospital das Clinicas da Universidade Federal de Goias · Goiânia, Brazil
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07204275
Collaborators
Zai Lab (Shanghai) Co., Ltd. (for China only)
Responsible party
Sponsor
First posted
Oct 2, 2025
Start date
Sep 30, 2025
Primary completion
Dec 29, 2028 (estimated)
Completion
Dec 29, 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Medical Information
Contact
medicalinfo@vrtx.com
001-617-341-6777

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Povetacicept

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