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

Phase 1RecruitingNCT06975787

Regeneron Pharmaceuticals90 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis (LN)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (19)

University of California San Francisco - Zuckerberg San Francisco General

San Francisco, California, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, United States

RECRUITING

Centre Hospitalier Universitaire (CHU) Bordeaux

Bordeaux, New Aquitaine, France

RECRUITING

University Hospital Regensburg

Regensburg, Bavaria, Germany

RECRUITING

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Germany

RECRUITING

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Yonsei University College of Medicine, Severance Hospital

Seoul, South Korea

RECRUITING

...and 9 more locations

Outcomes

Primary Outcomes

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

Secondary Outcomes

Proportion of participants no longer receiving a corticosteroid

Time frame: At 6 months

Cumulative total exposure to corticosteroids

Time frame: At 76 weeks

Absolute values of urine Protein-Creatinine Ratio (uPCR)

Time frame: Through week 76

Percent change from baseline of uPCR

Time frame: Through week 76

Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine

Time frame: Through week 76

Percent change from baseline of eGFR serum creatinine

Time frame: Through week 76

Absolute values of blood B-cell counts and other immune cell populations

T cells and Natural Killer (NK) cells

Time frame: Through week 76

Change from baseline of blood B-cell counts and other immune cell populations

T cells and NK cells

Time frame: Through week 76

Absolute values of double-stranded DNA (dsDNA) antibodies

Time frame: Through week 76

Percent change from baseline of dsDNA antibodies

Time frame: Through week 76

Absolute values of anti-Smith antibodies

Time frame: Through week 76

Percent change from baseline of anti-Smith antibodies

Time frame: Through week 76

Absolute values of anti-C1q antibodies

Time frame: Through week 76

Percent change from baseline of anti-C1q antibodies

Time frame: Through week 76

Absolute values of other autoantibodies

anti-nucleosome

Time frame: Through week 76

Percent change from baseline of other autoantibodies

anti-nucleosome

Time frame: Through week 76

Absolute values of Complement Factor C3 (C3) circulating factors

Time frame: Through week 76

Percent change from baseline of C3 circulating factors

Time frame: Through week 76

Absolute values of Complement Factor C4 (C4) circulating factors

Time frame: Through week 76

Percent change from baseline of C4 circulating factors

Time frame: Through week 76

Absolute values of serum levels of Immunoglobulin A (IgA)

Time frame: Through week 76

Percent change from baseline of serum levels of IgA

Time frame: Through week 76

Absolute values of serum levels of Immunoglobulin G (IgG)

Time frame: Through week 76

Percent change from baseline of serum levels of IgG

Time frame: Through week 76

Concentrations of vonsetamig in serum

Time frame: Through week 76

Concentrations of odronextamab in serum

Time frame: Through week 76

Occurence of Anti-Drug Antibodies (ADAs) to vonsetamig

Time frame: Through week 76

Occurence of ADAs to odronextamab

Time frame: Through week 76

Magnitude of ADAs to vonsetamig

Time frame: Through week 76

Magnitude of ADAs to odronextamab

Time frame: Through week 76

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

Overview

Conditions

Interventions

Eligibility

Locations (19)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts