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

a study on Lupus

Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jonathan Graf (ucsf)

Description

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)

Official Title

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

Keywords

Lupus Nephritis (LN), Bispecific Antibodies (bsAb), Double-stranded DNA (dsDNA), LN class III or IV, Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Systemic Lupus Erythematosus, Vonsetamig, Odronextamab

Eligibility

For people ages 18-60

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

  • University of California San Francisco - Zuckerberg San Francisco General accepting new patients
    San Francisco California 94110 United States
  • Baylor College of Medicine accepting new patients
    Houston Texas 77030 United States

Lead Scientist at University of California Health

  • Jonathan Graf (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 43 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT06975787
Phase
Phase 1 Lupus Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated
Contact us about this trial