Recruiting
Phase 1

Experimental Drugs

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06975787

Conditions

Lupus Nephritis (LN)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Vonsetamig

Odronextamab

Study Details

Brief summary:

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)

Conditions

Lupus Nephritis (LN)

Study ID

NCT06975787

Start date

Dec 22, 2025

Status verified date

Aug, 2026

Completion date

Sep 10, 2029

Anticipated

Primary completion date

Sep 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Key General Inclusion Criteria:

1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
2. Participant must have refractory or relapsed disease, as described in the protocol

Key General Exclusion Criteria:

1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm 1: Vonsetamig

experimental: Experimental Arm 2: Odronextamab

Interventions

Vonsetamig

Administered as per the protocol

Odronextamab

Administered as per the protocol

Primary outcome measure

  • Occurrence of Dose Limiting Toxicities (DLT) [ Time Frame: Up to 56 days ]
  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Through week 76 ]
  • Severity of TEAEs [ Time Frame: Through week 76 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Bispecific Antibodies (bsAb)
  • Double-stranded DNA (dsDNA)
  • LN class III or IV
  • Systemic Lupus Erythematosus (SLE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-13.