A Phase 3 study of Obexelimab in Patients with IgG4-Related Disease
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with IgG4-Related Disease (INDIGO)
IRAS ID
1006349
Contact name
Lisa Crockett
Contact email
Sponsor organisation
Zenas BioPharma (USA) LLC
Eudract number
2022-500718-24-00
Clinicaltrials.gov Identifier
Research summary
IgG4-Related Disease (IgG4-RD) is a rare condition that causes inflammation and scarring in many different areas of the body, including the pancreas, biliary tract, salivary glands and other organs. IgG4-RD can cause different symptoms and affect one or multiple organs. Most patients are middle aged to elderly men.
The current therapy for IgG4-RD consists of steroids followed by gradual withdrawal. This is initially effective, but 30 to 60% of patients will relapse after discontinued treatment. Long-term steroid therapy can cause several complications. Therefore, there is a need for novel treatment of IgG4-RD.
The purpose of this study is to evaluate the safety and effectiveness of obexelimab, on IgG4-RD. Obexelimab (a B cell targeted therapy) is an investigational drug, which means it has not yet been approved for the treatment of a disease by any regulatory agencies and can only be tested in a study like this one. There have been five studies of obexelimab with a total of 198 healthy volunteers or patients. A Phase 2 study in 20 participants with IgG4-RD showed strong and rapid improvement in their disease activity.
Approximately 200 adult participants are expected to take part globally. After an initial course of steroids, participants will enter a placebo-controlled period (a placebo is an inactive substance which resembles the study drug but has no medical value) where participants will receive obexelimab or placebo as a subcutaneous injection weekly for 52 weeks. At the end of the 52 weeks, participants may enter an open-label extension period, where all participants are given obexelimab for another 52 weeks. All participants will attend a follow-up visit when they complete the study. Study procedures include but are not limited to physical examination, vital signs, CT or MRI scan, blood samples, stool samples, quality of life questionnaires, glucocorticoid treatment and taper.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0015
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion