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

PHASE3RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

September 26, 2025

Primary Completion Date

June 28, 2028

Study Completion Date

December 25, 2030

Conditions
Immunoglobulin G4 Related Disease
Interventions
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

Trial Locations (6)

33063

RECRUITING

Life Clinical Trials- Site Number : 8400002, Margate

75093

RECRUITING

Stryde Research- Site Number : 8400011, Plano

75154

RECRUITING

Epic Medical Research (Red Oak)- Site Number : 8400003, Red Oak

95128

RECRUITING

San Jose Clinical Trials- Site Number : 8400016, San Jose

7500504

RECRUITING

Investigational Site Number : 1520003, Santiago

J1G 2E8

RECRUITING

Investigational Site Number : 1240001, Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT07190196 - A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease | Biotech Hunter | Biotech Hunter