A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

Summary

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Timeline

Start

2023-01-09

Primary completion

2025-11-13

Completion

2029-02-15

Outcome

Met primary endpoint

paper The time to the first disease flare that required rescue therapy was significantly longer with obexelimab than with placebo PMID 42233621 ↗

paper hazard ratio, 0.44; 95% confidence interval, 0.28 to 0.71; P<0.001 PMID 42233621 ↗

release “today announced positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint” zenasbio.com ↗

Publications

• Della-Torre E, Baker MC, Zhang W, Perugino CA, Katz G, Tanaka Y, Khosroshahi A, Kleger A, Schleinitz N, Martinez-Valle F, Schulze-Koops H, Nakayamada S, Rebours V, Okazaki K, Dong L, Carruthers M, Chen LYC, Frulloni L, Meysami A, Takahashi H, Kawano M, Liu Y, Saeki T, Ebbo M, Alexander T, Gonzalez Garcia A, Karadag O, Maslinska M, Quinn SM, Poma A, Wells A, Greene TJ, Stone JH, Culver EL; INDIGO Trial Investigators. Obexelimab for the Treatment of IgG4-Related Disease. N Engl J Med. 2026 Jun 2. doi: 10.1056/NEJMoa2601337. Online ahead of print.
• Culver EL, Baker MC, Della-Torre E, Zhang W, Perugino CA, Wells A, Mamuye A, Quinn SM, Poma A, Greene TJ, Stone JH. Efficacy and Safety of Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial. Rheumatol Ther. 2026 Jun;13(3):867-880. doi: 10.1007/s40744-026-00835-4. Epub 2026 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obexelimab	Monoclonal antibody	250 mg	Subcutaneous

Indications