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

NCT06975787 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 1

Started

2025-12-22

Last updated

2026-09-14

Condition(s) studied

Lupus Nephritis (LN)

Investigational drug(s) / intervention(s)

Vonsetamig →Odronextamab →

Vonsetamig: Administered as per the protocol

Odronextamab: Administered as per the protocol

Study 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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 outcome measure(s)

Occurrence of Dose Limiting Toxicities (DLT) — Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs) — Through week 76
Severity of TEAEs — Through week 76

Trial sites (19)

Facility	City	Region	Status
University of California San Francisco - Zuckerberg San Francisco General	San Francisco	California	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Baylor College of Medicine	Houston	Texas	Recruiting
Centre Hospitalier Universitaire (CHU) Bordeaux	Bordeaux	New Aquitaine	Recruiting
University Hospital Regensburg	Regensburg	Bavaria	Recruiting
University Medical Center of the Johannes Gutenberg-University Mainz	Mainz	Germany	Recruiting
Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do	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
Hospital Universitario Virgen del Rocio	Seville	Andalusia	Recruiting
Clinica Universidad de Navarra	Pamplona	Navarre	Recruiting
Hospital Gregorio Maranon	Madrid	Spain	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting
Hospital Regional Universitario de Malaga	Málaga	Spain	Recruiting
Changhua Christian Hospital	Changhua	Taiwan	Recruiting
Taichung General Veterans Hospital	Taichung	Taiwan	Recruiting
National Taiwan University Hospital	Taipei	Taiwan	Recruiting
Taipei Veterans General Hospital	Taipei	Taiwan	Recruiting

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Other trials for the same condition

A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G Recruiting

A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06975787 on ClinicalTrials.gov ↗ ← All trials in the USA