Recruiting
Phase 3

Rilzabrutinib

Sponsor:

Sanofi

Code:

NCT07190196

Conditions

Immunoglobulin G4 Related Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilzabrutinib

Placebo

Glucocorticoid

Study Details

Brief 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 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).

Conditions

Immunoglobulin G4 Related Disease

Study ID

NCT07190196

Start date

Sep 26, 2025

Status verified date

Jul, 2026

Completion date

Dec 25, 2030

Anticipated

Primary completion date

Jun 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rilzabrutinib

Rilzabrutinib

placebo comparator: Placebo

Placebo

Interventions

Rilzabrutinib

Pharmaceutical form:Tablet-Route of administration:Oral

Placebo

Pharmaceutical form:Tablet-Route of administration:Oral

Glucocorticoid

Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral

Primary outcome measure

  • Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period [ Time Frame: Until Week 52 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Kaiser Permanente - Fontana Medical Center- Site Number : 8400015

Recruiting

Fontana, California, United States, 92335

San Jose Clinical Trials- Site Number : 8400016

Recruiting

San Jose, California, United States, 95128

Contacts

Sara Viznyuk

408-443-3542sviznyuk@sanjosetrials.com

Principal Investigator:

Slawomir Wojtowicz-Praga

Solace Clinical Research - Tustin- Site Number : 8400020

Recruiting

Tustin, California, United States, 92780

Contacts

Hikyhe Ogannesian

562-652-0005hikyhe@salacecr.com

Principal Investigator:

Roger Kornu

Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002

Recruiting

Margate, Florida, United States, 33063

Contacts

Ana Auza

954-669-1052auza@ictresearch.com

Principal Investigator:

Jigar Shah

Schiff Center for Liver Diseases- Site Number : 8400010

Recruiting

Miami, Florida, United States, 33136

Vitalia Medical Research - Margate- Site Number : 8400025

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Delano Brooks

561-975-3684dbrooks@vitaliaresearch.com

Principal Investigator:

Clifford Stermer

Emory University School of Medicine - Atlanta- Site Number : 8400013

Recruiting

Atlanta, Georgia, United States, 30322

Primeway Clinical Research- Site Number : 8400019

Recruiting

Fayetteville, Georgia, United States, 30214

Contacts

Celine Lalu

678-368-7197celinek@primewayclinicalresearch.com

Principal Investigator:

Charlita Worthy

Massachusetts General Hospital- Site Number : 8400008

Recruiting

Boston, Massachusetts, United States, 02114

Mayo Clinic in Rochester - Minnesota- Site Number : 8400017

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Christian Coy

507-284-2175coy.christian@mayo.edu

Principal Investigator:

Motaz Ashkar

Cleveland Clinic - Cleveland- Site Number : 8400001

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Danielle Haas

216-385-2438haasd2@ccf.org

Principal Investigator:

James Fernandez

Ohio State University Wexner Medical Center- Site Number : 8400024

Recruiting

Columbus, Ohio, United States, 43215

Paramount Medical Research and Consulting LLC- Site Number : 8400018

Recruiting

Middleburg Heights, Ohio, United States, 44140

Contacts

Jackie Wittenmyer

440-826-0742jwittenmyer5@yahoo.com

Principal Investigator:

Isam Diab

Stryde Research- Site Number : 8400011

Recruiting

Plano, Texas, United States, 75093

Contacts

Jayshree Chouhan

214-407-8640jchouhan@stryderesearch.com

Principal Investigator:

Rahul Patel

Epic Medical Research - Red Oak- Site Number : 8400003

Recruiting

Red Oak, Texas, United States, 75154

Contacts

Siby Spurgeon

972-777-6956sspurgeon@epicmedresearch.com

Principal Investigator:

Sunny Patel

Digestive Health Research of North Texas- Site Number : 8400021

Recruiting

Wichita Falls, Texas, United States, 76301

Contacts

Sarah Sparkman

940-222-6675Sarah.sparkman@objective.health

Principal Investigator:

Vanya Wagler

Velocity Clinical Research - Seattle- Site Number : 8400005

Recruiting

Seattle, Washington, United States, 98105

Contacts

Christeen DeNeui

206-536-3030cdeneui@velocityclinical.com

Principal Investigator:

Kris Kowdley

Investigational Site Number : 1240001

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

More Information

Sponsor

Sanofi

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-28.