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

NCT07571746

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Primary Membranous Nephropathy

Interventions: Surovatamig

Countries: United States, Belgium, France, Germany, Italy, Poland, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (24)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Iowa City, Iowa, United States
  • Bethesda, Maryland, United States
  • New York, New York, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Ieper, Belgium
  • Bordeaux, France
  • Créteil, France
  • Lyon, France
  • Nantes, France
  • Nîmes, France
  • Düsseldorf, Germany
  • München, Germany
  • Brescia, Italy
  • Rozzano, Italy
  • Torino, Italy
  • Verona, Italy
  • Lodz, Poland
  • Barcelona, Spain
  • Madrid, Spain
  • London, United Kingdom
  • Manchester, United Kingdom