Efficacy and Safety of Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial - PubMed

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Obexelimab is being tested in a phase 3 trial (INDIGO) for treating IgG4-Related Disease (IgG4-RD), a chronic condition causing organ damage.
The trial is global, randomized, double-blind, and placebo-controlled, enrolling 194 patients to assess efficacy and safety.
Patients receive weekly subcutaneous obexelimab 250 mg or placebo for 52 weeks after glucocorticoid induction.
Primary endpoint: Time to first IgG4-RD flare requiring rescue therapy, assessed by both investigators and an adjudication committee.
Secondary endpoints include flare frequency, complete remission rates, and cumulative glucocorticoid dose.
The trial aims to provide evidence on B-cell inhibition as a treatment and evaluate obexelimab as a steroid-sparing option.
Ethical approval obtained, with the trial conducted in 19 countries following ICH GCP guidelines.

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