Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
NCT06975787 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-13
Summary
This study is researching a particular group of experimental drugs administered for a short period in the treatment of patients 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)
Conditions
- Lupus Nephritis (LN)
Interventions
- DRUG
-
Vonsetamig
Administered as per the protocol
- DRUG
-
Odronextamab
Administered as per the protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-22
- Primary Completion
- 2028-07-23
- Completion
- 2028-07-23
- FDA Drug
- Yes
Countries
- United States
- Germany
- South Korea
- Spain
- Taiwan
Study Locations
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