RecruitingPhase 2NCT07571746
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
Sponsor
AstraZeneca
Enrollment
43 participants
Start Date
Mar 28, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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.
- Diagnosis of anti-PLA2R antibody-positive pMN.
- 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.
- Positive for anti-PLA2R.
- Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
- 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.
- Capable of giving signed informed consent
Exclusion Criteria8
- Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies < 9 months before screening.
- Immunomodulatory therapy <3 months before screening.
- Secondary causes of membranous nephropathy
- Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
- Malignancies
- History of HLH/MAS. 7 Significant CNS co-morbidity
- \. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.
- \. 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGSurovatamig
Participants will receive Surovatamig subcutaneously
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07571746
Related Trials
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
NCT0655726518 locations
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
NCT0720427593 locations
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
NCT0696280093 locations
A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.
NCT0647019121 locations
A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
NCT056684036 locations