A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
AstraZeneca
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.
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-…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 institution…
Interventions
- DrugSurovatamig
Participants will receive Surovatamig subcutaneously
Locations (21)
- Research SiteLos Angeles, California
- Research SiteIowa City, Iowa
- Research SiteBethesda, Maryland
- Research SiteNew York, New York
- Research SiteHouston, Texas
- Research SiteHouston, Texas