Surovatamig for adults with anti‑PLA2R primary membranous nephropathy
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
This study will test whether subcutaneous surovatamig is safe and can reduce heavy proteinuria in adults with anti‑PLA2R–positive primary membranous nephropathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 21 sites (Los Angeles, California and 20 other locations) |
| Trial ID | NCT07571746 on ClinicalTrials.gov |
What this trial studies
This is a Phase II, open‑label, multi‑site study of subcutaneous surovatamig given in ascending multiple doses with sentinel dosing to adults who are anti‑PLA2R positive and have persistent heavy proteinuria. The trial has two parts (Part A and Part B), each with screening, treatment, and follow‑up periods, and total participation may last up to 26 months. Key outcomes include safety, tolerability, pharmacokinetics, and measures of efficacy such as changes in proteinuria and kidney function. Participants must generally be on standard ACE inhibitor or ARB therapy (unless contraindicated) before enrollment.
Who should consider this trial
Good fit: Adults aged 18–75 with anti‑PLA2R–positive primary membranous nephropathy who have heavy, persistent proteinuria and have been on ACE inhibitor or ARB therapy (unless intolerant) are the intended participants.
Not a fit: Patients who are anti‑PLA2R negative, have only low or transient proteinuria, already have end‑stage kidney disease, or have contraindications to the study drug are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, surovatamig could lower proteinuria and reduce the risk of progression to end‑stage kidney disease for people with anti‑PLA2R primary membranous nephropathy.
How similar studies have performed: Other treatments that target B cells or autoantibodies (for example, rituximab) have shown benefit in anti‑PLA2R membranous nephropathy, but surovatamig represents a novel therapeutic approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 20 other locations
- Research Site — Los Angeles, California, United States (Not_yet_recruiting)
- Research Site — Iowa City, Iowa, United States (Not_yet_recruiting)
- Research Site — Bethesda, Maryland, United States (Not_yet_recruiting)
- Research Site — New York, New York, United States (Not_yet_recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Houston, Texas, United States (Not_yet_recruiting)
- Research Site — Ieper, Belgium (Not_yet_recruiting)
- Research Site — Bordeaux, France (Not_yet_recruiting)
- Research Site — Créteil, France (Withdrawn)
- Research Site — Lyon, France (Not_yet_recruiting)
- Research Site — Nantes, France (Not_yet_recruiting)
- Research Site — Nîmes, France (Not_yet_recruiting)
- Research Site — Düsseldorf, Germany (Not_yet_recruiting)
- Research Site — Brescia, Italy (Not_yet_recruiting)
- Research Site — Rozzano, Italy (Not_yet_recruiting)
- Research Site — Torino, Italy (Not_yet_recruiting)
- Research Site — Verona, Italy (Withdrawn)
- Research Site — Lodz, Poland (Not_yet_recruiting)
- Research Site — Barcelona, Spain (Not_yet_recruiting)
- Research Site — Madrid, Spain (Not_yet_recruiting)
- Research Site — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.