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

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs Inebilizumab 300 mg; Hazard Ratio (HR) 0.13 (95% CI 0.06 to 0.28) NCT04540497 ↗

paper 7 participants (10%) in the inebilizumab group had at least one flare, as compared with 40 participants (60%) in the placebo group PMID 39541094 ↗

release “The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo” amgen.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Inebilizumab	Monoclonal antibody	300 mg	Intravenous

Indications