Surovatamig for adults with anti‑PLA2R primary membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Houston, Texas, United States Recruiting
• Research Site
  Los Angeles, California, United States Withdrawn
• 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

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SHR-2173 injections for adults with primary membranous nephropathy

  This Phase II test will try SHR-2173 injections in adults (18–75) with biopsy-proven primary membranous nephropathy to see if they are safe, reduce disease activity, and to measure how the drug acts in the body.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Nanjing, Jiangsu · NCT07289763

• Povetacicept for people with primary membranous nephropathy

  This trial tests whether povetacicept is safe and helps people with primary membranous nephropathy, with tacrolimus listed as an intervention in the protocol.

  Recruiting at 116 sites Phase 2/3 Vertex Pharmaceuticals Incorporated · Montgomery, Alabama and 116 other locations · NCT07204275

• ALXN1920 for adults with primary membranous nephropathy

  This trial will test whether ALXN1920 reduces urine protein in adults with primary membranous nephropathy who are at high risk of progression compared with placebo.

  Recruiting at 35 sites Phase 2 Alexion Pharmaceuticals, Inc. · Loma Linda, California and 39 other locations · NCT07157787

• Budoprutug for primary membranous nephropathy (Phase 2)

  This trial will test whether budoprutug, an anti-CD19 antibody given by IV, is safe and tolerated and may reduce proteinuria in adults with PLA2R-positive primary membranous nephropathy who still have high protein in their urine despite RAAS blockers.

  Recruiting at 35 sites Phase 2 Climb Bio, Inc. · Denver, Colorado and 37 other locations · NCT07096843

• Evaluating YK012 for treating primary membranous nephropathy

  This study is testing a new treatment called YK012 to see if it can help people with primary membranous nephropathy feel better and how safe it is to use.

  Recruiting Phase 1 Excyte Biopharma Ltd · Beijing, Beijing Municipality · NCT06982729

• Felzartamab infusions for adults with primary membranous nephropathy

  This study tests whether felzartamab infusions help adults with primary membranous nephropathy reach complete remission of proteinuria compared with tacrolimus.

  Recruiting at 116 sites Phase 3 Biogen · Huntsville, Alabama and 116 other locations · NCT06962800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.