Clinical trial NCT06975787: Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
Official title: A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Lupus Nephritis (LN)
Keywords: Bispecific Antibodies (bsAb)
Double-stranded DNA (dsDNA)
LN class III or IV
Systemic Lupus Erythematosus (SLE)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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)


Eligibility 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

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicities (DLT)
timeFrame: Up to 49 days
measure: Occurrence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Through week 52
measure: Severity of TEAEs
timeFrame: Through week 52
Secondary outcomes:
measure: Proportion of participants receiving a corticosteroid dose of 0 mg per day
timeFrame: At 6 months
measure: Cumulative total exposure to corticosteroids
timeFrame: At 52 weeks
measure: Absolute values of urine Protein-Creatinine Ratio (uPCR)
timeFrame: Through week 52
measure: Percent change from baseline of uPCR
timeFrame: Through week 52
measure: Absolute values of estimated Glomerular Filtration Rate (eGFR) serum creatinine
timeFrame: Through week 52
measure: Percent change from baseline of eGFR serum creatinine
timeFrame: Through week 52
measure: Absolute values of blood B-cell counts and other immune cell populations
timeFrame: Through week 52
measure: Change from baseline of blood B-cell counts and other immune cell populations
timeFrame: Through week 52
measure: Absolute values of double-stranded DNA (dsDNA) antibodies
timeFrame: Through week 52
measure: Percent change from baseline of dsDNA antibodies
timeFrame: Through week 52
measure: Absolute values of anti-Smith antibodies
timeFrame: Through week 52
measure: Percent change from baseline of anti-Smith antibodies
timeFrame: Through week 52
measure: Absolute values of anti-C1q antibodies
timeFrame: Through week 52
measure: Percent change from baseline of anti-C1q antibodies
timeFrame: Through week 52
measure: Absolute values of other autoantibodies
timeFrame: Through week 52
measure: Percent change from baseline of other autoantibodies
timeFrame: Through week 52
measure: Absolute values of Complement Factor C3 (C3) circulating factors
timeFrame: Through week 52
measure: Percent change from baseline of C3 circulating factors
timeFrame: Through week 52
measure: Absolute values of Complement Factor C4 (C4) circulating factors
timeFrame: Through week 52
measure: Percent change from baseline of C4 circulating factors
timeFrame: Through week 52
measure: Absolute values of serum levels of Immunoglobulin A (IgA)
timeFrame: Through week 52
measure: Percent change from baseline of serum levels of IgA
timeFrame: Through week 52
measure: Absolute values of serum levels of Immunoglobulin G (IgG)
timeFrame: Through week 52
measure: Percent change from baseline of serum levels of IgG
timeFrame: Through week 52
measure: Concentrations of study drug in serum over time
timeFrame: Through week 52
measure: Incidence of Anti-Drug Antibodies (ADAs) to study drug
timeFrame: Through week 52
measure: Titer of ADAs to study drug
timeFrame: Through week 52
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: