A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Summary

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

Timeline

Start

2020-12-04

Primary completion

2024-04-09

Completion

2028-10-31

Publications

• Tanaka Y, Umehara H, Sato H, Uchima K, Kouji K, Okazaki K. Inebilizumab treatment in Japanese patients with IgG4-related disease: a subgroup analysis of a randomized, double-blind, placebo-controlled, phase 3 trial (MITIGATE). Mod Rheumatol. 2026 Mar 6:roag020. doi: 10.1093/mr/roag020. Online ahead of print.
• Stone JH, Khosroshahi A, Zhang W, Della Torre E, Okazaki K, Tanaka Y, Lohr JM, Schleinitz N, Dong L, Umehara H, Lanzillotta M, Wallace ZS, Ebbo M, Webster GJ, Martinez Valle F, Nayar MK, Perugino CA, Rebours V, Dong X, Wu Y, Li Q, Rampal N, Cimbora D, Culver EL; MITIGATE Trial Investigators. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2025 Mar 27;392(12):1168-1177. doi: 10.1056/NEJMoa2409712. Epub 2024 Nov 14.
• Perugino C, Culver EL, Khosroshahi A, Zhang W, Della-Torre E, Okazaki K, Tanaka Y, Lohr M, Schleinitz N, Falloon J, She D, Cimbora D, Stone JH. Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2023 Dec;10(6):1795-1808. doi: 10.1007/s40744-023-00593-7. Epub 2023 Oct 4.

Drugs

Indications