BridgeMD
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease
EU CTIS ID: 2025-524139-38-00
What this study is testing
To assess the safety and tolerability of surovatamig. To assess the effect of surovatamig on proteinuria.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 of signing the informed consent.
- Diagnosis of anti-PLA2R antibody-positive pMN according to KDIGO 2021 guidelines.
- 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.
- eGFR ≥ XXmL/min/1.73m2 (using the 2021 CKD-EPI creatinine equation).
- Positive for anti-PLA2R.
- Adequate haematological function.
You likely can't join if
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
- Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.
- Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.
- History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks from signing ICF).
- Participant with current or previous active or latent TB. Participant will be excluded from the study if any of the following criteria are met: (a) Signs or symptoms of active TB prior to or during screening. (b) Medical history or past physical examinations suggestive of active or latent TB. (c) A chest X-ray during the screening period or a chest X-ray or CT scan within 12 weeks prior to signing of the ICF with evidence of active or signs of prior TB infection. (d) Household contact with a person with active TB. (e) The participant must undergo a TB screen (QuantiFERON-TB Gold test), confirmed by the central laboratory at the screening visit. Participant will be excluded from the study with any of the following results: (i) Positive result. (ii) Indeterminate result. Test may be repeated once, no earlier than 2 months later. If upon retest the result is indeterminate, the participant is declared a screen failure.
- Participant with HIV infection (confirmed by central laboratory at screening).
See the full eligibility criteria
Who can join
- 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 according to KDIGO 2021 guidelines.
- 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.
- eGFR ≥ XXmL/min/1.73m2 (using the 2021 CKD-EPI creatinine equation).
- Positive for anti-PLA2R.
- Adequate haematological function.
- Blood CD19+ B cells ≥ XX cells/μL at screening.
- IgG levels ≥ XX g/L at screening.
- 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.
What rules you out
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
- Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.
- Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.
- History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks from signing ICF).
- Participant with current or previous active or latent TB. Participant will be excluded from the study if any of the following criteria are met: (a) Signs or symptoms of active TB prior to or during screening. (b) Medical history or past physical examinations suggestive of active or latent TB. (c) A chest X-ray during the screening period or a chest X-ray or CT scan within 12 weeks prior to signing of the ICF with evidence of active or signs of prior TB infection. (d) Household contact with a person with active TB. (e) The participant must undergo a TB screen (QuantiFERON-TB Gold test), confirmed by the central laboratory at the screening visit. Participant will be excluded from the study with any of the following results: (i) Positive result. (ii) Indeterminate result. Test may be repeated once, no earlier than 2 months later. If upon retest the result is indeterminate, the participant is declared a screen failure.
- Participant with HIV infection (confirmed by central laboratory at screening).
- Participant with active EBV or CMV, assessed clinically.
- Participant with evidence of chronic or active hepatitis B, defined as HBsAg positive or HBcAb positive (tested at screening visit).
- Participant with evidence of chronic or active hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA > 12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).
- Abnormal vital sign after 10 minutes sitting at rest.
- ECG abnormalities that, in the Investigator’s opinion, make the participant unsuitable for study participation.
- Secondary causes of membranous nephropathy (autoimmune or infectious diseases, neoplasms, etc), HIV infection, liver disease.
- Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent < 2 months before screening.
- Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) < 9 months before screening.
- Immunomodulatory therapy <3 months before screening.
- Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
- Malignancies: • Concurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ, and low-risk prostate cancer being monitored without treatment. • Any malignancy within the past 3 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or low risk prostate cancer without evidence of progression. • Case-by-case investigators review for rare malignancies with definitive cure and minimal recurrence risk when supported by documentation from the treating oncologist.
- History of HLH/MAS.
- Significant CNS co-morbidity (eg, Parkinson’s, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy/seizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).
- Recent history (within 6 months of signing ICF) or current diagnosis of ongoing clinically significant specific diseases as per protocol.
- Significant opportunistic infection in the medical history deemed relevant by the Investigator.
- Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. 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 EU CTIS; the study team decides eligibility.