Surovatamig: Participants will receive Surovatamig subcutaneously
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
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 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.
Primary outcome measure(s)
Number of participants with adverse events. — Through study completion, an average of 2 years To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig.
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) — At 6 months To assess the effect of surovatamig on proteinuria
Trial sites (24)
Facility
City
Region
Status
Research Site
Los Angeles
California
Withdrawn
Research Site
Los Angeles
California
Not Yet Recruiting
Research Site
Iowa City
Iowa
Not Yet Recruiting
Research Site
Bethesda
Maryland
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
Houston
Texas
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
München
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
London
United Kingdom
Not Yet Recruiting
Research Site
Manchester
United Kingdom
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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