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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Lupus Nephritis (LN)

Treatments: Drug: Vonsetamig; Drug: Odronextamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06975787

2024-518288-37-00 (Registry Identifier)

R5459-1979-LN-2459

Details and patient eligibility

About

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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Experimental Arm 1: Vonsetamig

Experimental group

Treatment:

Drug: Vonsetamig

Experimental Arm 2: Odronextamab

Experimental group

Treatment:

Drug: Odronextamab