Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Regeneron Pharmaceuticals · NCT06975787
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–60 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 90
- US sites recruiting
- 3
- Study start
- December 22, 2025
- Record last updated
- September 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).
The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.
This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Being studied: Vonsetamig; Odronextamab
Conditions: Lupus Nephritis (LN)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key General Inclusion Criteria
- Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
- Participant must have refractory or relapsed disease, as described in the protocol
Key General Exclusion Criteria
- History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
NOTE: Other protocol defined inclusion/exclusion criteria apply
Recruiting US locations
University of California San Francisco - Zuckerberg San Francisco General
San Francisco, CA 94110
Mayo Clinic
Rochester, MN 55905
Baylor College of Medicine
Houston, TX 77030
Study contacts (from the official record)
- Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com
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