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New treatment option for Primary Membranous Nephropathy
Official title A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
ClinicalTrials.gov ID: NCT07571746
What this study is testing
What is Surovatamig?
Surovatamig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- Positive for anti-PLA2R.
- Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus...
You likely can't join if
- 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 8\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in...
See the full eligibility criteria
- 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...
- 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...
- Capable of giving signed informed consent
- 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 8\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator. 10\. Abnormal...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Iowa City, Iowa, United States
- Bethesda, Maryland, United States
- New York, New York, United States
- Houston, Texas, United States
- Ieper, Belgium
- Bordeaux, France
- Créteil, France
- Lyon, France
- Nantes, France
- Nîmes, France
- Düsseldorf, Germany
- Brescia, Italy
- Rozzano, Italy
- Torino, Italy
- Verona, Italy
- Lodz, Poland
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Iowa City, Iowa, United States; Bethesda, Maryland, United States; New York, New York, United States; Houston, Texas, United States; Ieper, Belgium and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.