NCT07190196

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD. The purpose of this study is to measure time to IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period. Study details include: The study duration will be up to 60 weeks, including a 4 to 6-week screening period, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks). The number of visits will be 16 (plus an optional 9 visits during the OLE).

Conditions

• Immunoglobulin G4 Related Disease

Interventions

Type	Name	Description
DRUG	Rilzabrutinib	Pharmaceutical form:Tablet-Route of administration:Oral
DRUG	Placebo	Pharmaceutical form:Tablet-Route of administration:Oral
DRUG	Glucocorticoid	Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral

Timeline

• Start date: 2025-09-26
• Primary completion: 2028-06-28
• Completion: 2030-12-25
• First posted: 2025-09-24
• Last updated: 2026-04-08

Locations

66 sites across 19 countries: United States, Argentina, Belgium, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study