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Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
NCT06975787 · Regeneron Pharmaceuticals
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis
About this study
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
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2025-12-22
Estimated completion: 2028-07-23
Last updated: 2026-04-13
Interventions
Drug: VonsetamigDrug: Odronextamab
Primary outcomes
- • 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)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (11)
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
University Medical Center of the Johannes Gutenberg-University MainzRecruiting
Mainz, Germany
Hallym University Sacred Heart HospitalRecruiting
Anyang-si, Gyeonggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Taichung General Veterans HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan