NCT07571746

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
42mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
8 countries

21 active sites

Status
recruiting

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

Study Progress3%
Mar 2026Oct 2029

First Submitted

Initial submission to the registry

March 19, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

March 19, 2026

Last Update Submit

April 30, 2026

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events.

    To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig.

    Through study completion, an average of 2 years

  • Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)

    To assess the effect of surovatamig on proteinuria

    At 6 months

Secondary Outcomes (12)

  • Percentage of participants achieving complete or partial remission of pMN

    At 24 months

  • Percentage of participants achieving complete remission of pMN

    At 24 months

  • Percentage of participants achieving partial remission of pMN

    At 24 months

  • Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)

    At 24 months

  • Change from baseline in anti-PLA2R antibody titer

    At 24 months

  • +7 more secondary outcomes

Study Arms (1)

Surovatamig Arm

EXPERIMENTAL

Participants will receive Surovatamig

Drug: Surovatamig

Interventions

SurovatamigDRUG

Participants will receive Surovatamig subcutaneously

Surovatamig Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
  • Diagnosis of anti-PLA2R antibody-positive pMN.
  • All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.
  • Positive for anti-PLA2R.
  • Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
  • Male and/or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent

You may not qualify if:

  • Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies \< 9 months before screening.
  • Immunomodulatory therapy \<3 months before screening.
  • Secondary causes of membranous nephropathy
  • Diabetes mellitus with haemoglobin A1C \> 8.5% tested at screening visit.
  • Malignancies
  • History of HLH/MAS. 7 Significant CNS co-morbidity
  • \. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.
  • \. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent \< 2 months before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Research Site

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Research Site

Bethesda, Maryland, 20889, United States

NOT YET RECRUITING

Research Site

New York, New York, 10016, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77027, United States

RECRUITING

Research Site

Houston, Texas, 77030, United States

NOT YET RECRUITING

Research Site

Ieper, 8900, Belgium

NOT YET RECRUITING

Research Site

Bordeaux, 33076, France

NOT YET RECRUITING

Research Site

Créteil, 94010, France

WITHDRAWN

Research Site

Lyon, 69009, France

NOT YET RECRUITING

Research Site

Nantes, 44093, France

NOT YET RECRUITING

Research Site

Nîmes, 30029, France

NOT YET RECRUITING

Research Site

Düsseldorf, 40225, Germany

NOT YET RECRUITING

Research Site

Brescia, 25123, Italy

NOT YET RECRUITING

Research Site

Rozzano, 20089, Italy

NOT YET RECRUITING

Research Site

Torino, 10154, Italy

NOT YET RECRUITING

Research Site

Verona, 37126, Italy

WITHDRAWN

Research Site

Lodz, 92-213, Poland

NOT YET RECRUITING

Research Site

Barcelona, 08025, Spain

NOT YET RECRUITING

Research Site

Madrid, 28041, Spain

NOT YET RECRUITING

Research Site

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The study consists of 2 parts (Part A and Part B), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

May 6, 2026

Study Start

March 28, 2026

Primary Completion (Estimated)

April 24, 2028

Study Completion (Estimated)

October 15, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

ES(2)PL(1)IT(4)US(6)BE(1)FR(5)GB(1)DE(1)