Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06975787
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lupus Nephritis (LN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Vonsetamig — DRUG
    Administered as per the protocol
  • Odronextamab — DRUG
    Administered as per the protocol

Study Details

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)

Key Dates

Start date
Dec 22, 2025
Status verified
Jun 2026
Primary completion
Sep 9, 2029
Completion
Sep 9, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm 1: Vonsetamig
  • Experimental: Experimental Arm 2: Odronextamab

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: Up to 56 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Rochester, MN

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Mayo Clinic· Rochester, MNBaylor College of Medicine· Houston, TX

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