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
- Immunoglobulin G4 Related Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Sanofi
- Enrolment target
- 124
- Started
- 26 September 2025
- Main results due
- 28 June 2028
- Study sites
- 92
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Participants must have a clinical diagnosis of IgG4-RD confirmed by the Adjudication Committee. * Participants meeting Step 1 Entry criteria of 2019 ACR/EULAR classification criteria for IgG4-RD and Total inclusion points are ≥20 * Participants with active disease in at least 1 organ system, excluding lymph nodes, with active disease defined by an IgG4-RD Responder Index organ/site activity score ≥2 based on the manifestations of disease activity in the last 28 days. * Participants with history or current involvement of at least 1 organ/site (excluding lymph nodes) affected with IgG4-RD. * Participants with active IgG4-RD controlled for at least 2 weeks while on a stable dose of GC. * Participants willing to taper off GC after starting IMP. * Participants willing and able to participate in repeated study protocol mandated or clinically indicated imaging procedures to assess IgG4-RD such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), or ultrasound. * Participants who have an up-to-date vaccination status as per local guidelines. The last dose of live vaccines should be received at least 30 days before Day 1. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Meet any Step 2 Exclusion criteria from the 2019 ACR/EULAR classification criteria for IgG4-RD. * History of retroperitoneal fibrosis, sclerosing mesenteritis, fibrosing mediastinitis, or other overwhelmingly fibrotic expression of IgG4-RD that is the sole disease manifestation. * Active malignancy or history of malignancy within 5 years before Day 1, except completely treated in situ carcinoma of the cervix, completely treated, and resolved nonmetastatic squamous or basal cell carcinoma of the skin. * Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator. * History of serious infections with the potential for recurrence (as judged by the Investigator), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher). * Current or chronic history of liver disease unrelated to IgG4-RD. * Refractory nausea and vomiting, malabsorption, external biliary shunt, bariatric surgery, or significant bowel resection that would preclude adequate rilzabrutinib/placebo absorption. * History of solid organ transplant. * Planned major surgical procedure during the participation in this study. * History of drug abuse within the previous 12 months. * Alcoholism or excessive alcohol use, defined as regular consumption of more than approximately 3 standard drinks per day. * Prior participation in any rilzabrutinib studies or other BTK inhibitor studies. * History of treatment with an investigational drug within 6 months or 5 half-lives of the investigational drug, whichever is longer. * Laboratory abnormalities at the screening visit identified by the central laboratory The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
What this study is about
In the sponsor’s own words, from the registry.
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 adjudicated 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 Screening period of 4 to 6 weeks, 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).
Study sites(92)
Kaiser Permanente - Fontana Medical Center- Site Number : 8400015
Fontana, California, United States
Recruiting
University of California Davis Health- Site Number : 8400012
Sacramento, California, United States
Recruiting
San Jose Clinical Trials- Site Number : 8400016
San Jose, California, United States
Recruiting
Solace Clinical Research - Tustin- Site Number : 8400020
Tustin, California, United States
Recruiting
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002
Margate, Florida, United States
Recruiting
Vitalia Medical Research - Margate- Site Number : 8400025
Palm Beach Gardens, Florida, United States
Recruiting
Emory University School of Medicine - Atlanta- Site Number : 8400013
Atlanta, Georgia, United States
Recruiting
Primeway Clinical Research- Site Number : 8400019
Fayetteville, Georgia, United States
Recruiting
Massachusetts General Hospital- Site Number : 8400008
Boston, Massachusetts, United States
Recruiting
Henry Ford Hospital- Site Number : 8400009
Detroit, Michigan, United States
Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400017
Rochester, Minnesota, United States
Recruiting
Icahn School of Medicine at Mount Sinai- Site Number : 8400014
New York, New York, United States
Recruiting
Cleveland Clinic - Cleveland- Site Number : 8400001
Cleveland, Ohio, United States
Recruiting
Ohio State University Wexner Medical Center- Site Number : 8400024
Columbus, Ohio, United States
Recruiting
Paramount Medical Research and Consulting LLC- Site Number : 8400018
Middleburg Heights, Ohio, United States
Recruiting
Stryde Research- Site Number : 8400011
Plano, Texas, United States
Recruiting
Epic Medical Research - Red Oak- Site Number : 8400003
Red Oak, Texas, United States
Recruiting
Digestive Health Research of North Texas- Site Number : 8400021
Wichita Falls, Texas, United States
Recruiting
Velocity Clinical Research - Seattle- Site Number : 8400005
Seattle, Washington, United States
Recruiting
Investigational Site Number : 0320005
Berazategui, Buenos Aires, Argentina
Recruiting
Investigational Site Number : 0320003
San Isidro, Buenos Aires, Argentina
Recruiting
Investigational Site Number : 0320004
Buenos Aires, Argentina
Recruiting
Investigational Site Number : 0320002
Buenos Aires, Argentina
Recruiting
Investigational Site Number : 0320006
Buenos Aires, Argentina
Recruiting
Investigational Site Number : 0560001
Leuven, Belgium
Recruiting
Investigational Site Number : 1240004
Montreal, Quebec, Canada
Recruiting
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada
Recruiting
Investigational Site Number : 1520005
Concepción, Biobio, Chile
Recruiting
Investigational Site Number : 1520006
Puente Alto, Reg Metropolitana de Santiago, Chile
Recruiting
Centro de estudios G y C-Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Recruiting
Investigational Site Number : 1560008
Beijing, China
Recruiting
Investigational Site Number : 1560004
Beijing, China
Recruiting
Investigational Site Number : 1560001
Beijing, China
Recruiting
Investigational Site Number : 1560012
Chengdu, China
Recruiting
Investigational Site Number : 1560010
Hangzhou, China
Recruiting
Investigational Site Number : 1560003
Jiazhuang, China
Recruiting
Investigational Site Number : 1560013
Taiyuan, China
Recruiting
Investigational Site Number : 1560005
Taiyuan, China
Recruiting
Investigational Site Number : 1560011
Wuhan, China
Recruiting
Investigational Site Number : 1560009
Yantai, China
Recruiting
AP-HP - Hôpital Beaujon-Site Number : 2500002
Clichy, France
Active, not recruiting
Investigational Site Number : 2500004
Dijon, France
Recruiting
Investigational Site Number : 2500005
Lille, France
Recruiting
Investigational Site Number : 2500006
Lyon, France
Recruiting
Investigational Site Number : 2500001
Marseille, France
Recruiting
CHU Bordeaux - Hôpital Haut Leveque-Site Number : 2500003
Pessac, France
Active, not recruiting
Investigational Site Number : 2500007
Suresnes, France
Recruiting
Investigational Site Number : 2760001
Berlin, Germany
Recruiting
Investigational Site Number : 2760003
Erlangen, Germany
Recruiting
Investigational Site Number : 2760007
Hanover, Germany
Recruiting
Investigational Site Number : 2760004
Minden, Germany
Recruiting
Investigational Site Number : 2760006
Ulm, Germany
Recruiting
Rabin MC, Outpatient Clinics Building-Site Number : 3760001
Petah Tikva, Central District, Israel
Recruiting
Sourasky Rheumatology Dept, Rishonim Building-Site Number : 3760005
Tel Aviv, Central District, Israel
Recruiting
Investigational Site Number : 3760006
Kefar Sava, Israel
Recruiting
Investigational Site Number : 3760003
Nahariya, Israel
Recruiting
AOU Meyer IRCCS-Site Number : 3800003
Florence, Firenze, Italy
Recruiting
IRCCS Ospedale San Raffaele-Site Number : 3800001
Milan, Lombardy, Italy
Recruiting
Showing 60 of 92 sites — filter to narrow it down. 88 of the 92 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07190196. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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