A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease (CLEAR-AbKD)

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Membranous Nephropathy
• Intervention / Treatment: Drug: Surovatamig

Detailed Description

This is a Phase II open-label study to assess the safety, tolerability, Pharmacokinetics, and efficacy of surovatamig in adult participants with pMN, who are positive for anti-PLA2R antibodies and have heavy and persistent proteinuria with a high risk of progressing to end stage kidney disease.

The study will be conducted across approximately 30 to 40 study sites in approximately 10 countries. The study consists of 2 parts (Part A Multiple ascending with sentinel dosing and Part B Multiple ascending doses), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Belgium
  • Ieper, Belgium, 8900
    • Not yet recruiting
    • Research Site
• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Research Site
  • Créteil, France, 94010
    • Withdrawn
    • Research Site
  • Lyon, France, 69009
    • Not yet recruiting
    • Research Site
  • Nantes, France, 44093
    • Not yet recruiting
    • Research Site
  • Nîmes, France, 30029
    • Not yet recruiting
    • Research Site
• Germany
  • Düsseldorf, Germany, 40225
    • Not yet recruiting
    • Research Site
• Italy
  • Brescia, Italy, 25123
    • Not yet recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Research Site
  • Torino, Italy, 10154
    • Not yet recruiting
    • Research Site
  • Verona, Italy, 37126
    • Withdrawn
    • Research Site
• Poland
  • Lodz, Poland, 92-213
    • Not yet recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08025
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Research Site
• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Not yet recruiting
    • Research Site
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Not yet recruiting
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Not yet recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Research Site
    • Houston, Texas, United States, 77027
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Diagnosis of anti-PLA2R antibody-positive pMN.
3. 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.
4. Positive for anti-PLA2R.
5. Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
6. 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.
7. Capable of giving signed informed consent

Exclusion Criteria:

1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies < 9 months before screening.
2. Immunomodulatory therapy <3 months before screening.
3. Secondary causes of membranous nephropathy
4. Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
5. Malignancies
6. History of HLH/MAS. 7 Significant CNS co-morbidity

8. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.

10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surovatamig Arm; Participants will receive Surovatamig	Drug: Surovatamig; Participants will receive Surovatamig subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants achieving complete or partial remission of pMN	To evaluate the proportion of participants who achieve partial and/or complete remission	At 24 months
Percentage of participants achieving complete remission of pMN	To evaluate the proportion of participants who achieved complete remission	At 24 months
Percentage of participants achieving partial remission of pMN	To evaluate the proportion of participants who achieve partial remission	At 24 months
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 24 months
Change from baseline in anti-PLA2R antibody titer	To evaluate anti-PLA2R antibodies in blood	At 24 months
Change from baseline in B-cell count in peripheral blood	To assess the effect of surovatamig by assessment of B-cell depletion in blood	At 24 months
Time to relapse after complete or partial remission	Time to relapse after complete or partial remission	At 24 months
Time to a ≥ 3 months sustained reduction of eGFR	Time to a sustained reduction of eGFR	From Baseline to 24 months
Change from baseline in patient-reported experience of symptoms associated with pMN	To evaluate the change in patient-reported experience	Through study completion, an average of 2 years
Serum PK parameters of surovatamig, AUC Area under the plasma concentration versus time curve	To characterise the PK of surovatamig	Through study completion, an average of 2 years
Treatment-emergent ADAs	To evaluate the immunogenicity of surovatamig	Through study completion, an average of 2 years
Serum PK parameters of surovatamig, as Cmax (Peak Plasma Concentration)	To characterise the PK of surovatamig	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2026
• Primary Completion (Estimated): April 24, 2028
• Study Completion (Estimated): October 15, 2029

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D740FC00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No