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New pill aims to tame rare inflammatory disease

NCT ID NCT07190196

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This phase 3 study tests whether the oral drug rilzabrutinib can prevent disease flares in adults with active IgG4-related disease, a rare condition causing swelling and organ damage. About 124 participants will receive either rilzabrutinib or a placebo for 52 weeks, alongside standard glucocorticoids. The main goal is to see how long it takes for a flare to occur, and whether the drug helps reduce steroid use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilzabrutinib (a tablet taken by mouth)
What this could lead to
If it works, this could offer a new treatment option to control IgG4-related disease and reduce the need for steroids.
What could go wrong
This is a phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunoglobulin G4-related disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    75 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Meyer IRCCS-Site Number : 3800003

    RECRUITING

    Florence, Firenze, 50139, Italy

  • AP-HP - Hôpital Beaujon-Site Number : 2500002

    ACTIVE_NOT_RECRUITING

    Clichy, 92110, France

  • CHU Bordeaux - Hôpital Haut Leveque-Site Number : 2500003

    ACTIVE_NOT_RECRUITING

    Pessac, 33600, France

  • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi-Site Number : 3800002

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Centro de estudios G y C-Site Number : 1520003

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 7500504, Chile

  • Cleveland Clinic - Cleveland- Site Number : 8400001

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Digestive Health Research of North Texas- Site Number : 8400021

    RECRUITING

    Wichita Falls, Texas, 76301, United States

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

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Epic Medical Research - Red Oak- Site Number : 8400003

    RECRUITING

    Red Oak, Texas, 75154, United States

  • Erasmus Medisch Centrum-Site Number : 5280001

    ACTIVE_NOT_RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Hiroshima University Hospital-Site Number : 3920007

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • IRCCS Ospedale San Raffaele-Site Number : 3800001

    RECRUITING

    Milan, Lombardy, 20132, Italy

  • Investigational Site Number : 0320002

    RECRUITING

    Resistencia, Chaco Province, 3500, Argentina

  • Investigational Site Number : 0320003

    RECRUITING

    San Isidro, Buenos Aires, B1643CRO, Argentina

  • Investigational Site Number : 0320004

    RECRUITING

    Buenos Aires, 1015, Argentina

  • Investigational Site Number : 0320005

    RECRUITING

    Berazategui, Buenos Aires, 1886, Argentina

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 1240001

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Investigational Site Number : 1520001

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8320325, Chile

  • Investigational Site Number : 1520002

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8330032, Chile

  • Investigational Site Number : 1520005

    RECRUITING

    Concepción, Biobio, 4070038, Chile

  • Investigational Site Number : 1520006

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8207257, Chile

  • Investigational Site Number : 1560001

    RECRUITING

    Beijing, 100730, China

  • Investigational Site Number : 1560003

    RECRUITING

    Jiazhuang, 050000, China

  • Investigational Site Number : 1560004

    RECRUITING

    Beijing, 100050, China

  • Investigational Site Number : 1560005

    RECRUITING

    Taiyuan, 030032, China

  • Investigational Site Number : 1560008

    RECRUITING

    Beijing, 100034, China

  • Investigational Site Number : 1560009

    RECRUITING

    Yantai, 264001, China

  • Investigational Site Number : 1560010

    RECRUITING

    Hangzhou, 310009, China

  • Investigational Site Number : 1560011

    RECRUITING

    Wuhan, 430030, China

  • Investigational Site Number : 1560012

    RECRUITING

    Chengdu, 610041, China

  • Investigational Site Number : 1560013

    RECRUITING

    Taiyuan, 030001, China

  • Investigational Site Number : 1580001

    RECRUITING

    Taipei, 10016, Taiwan

  • Investigational Site Number : 1580002

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Investigational Site Number : 1580004

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 2500001

    RECRUITING

    Marseille, 13885, France

  • Investigational Site Number : 2760001

    RECRUITING

    Berlin, 13353, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Erlangen, 91054, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Minden, 32429, Germany

  • Investigational Site Number : 2760006

    RECRUITING

    Ulm, 89081, Germany

  • Investigational Site Number : 3920001

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Investigational Site Number : 3920003

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Investigational Site Number : 3920004

    RECRUITING

    Kitakyushu, Fukuoka, 807-8555, Japan

  • Investigational Site Number : 3920005

    RECRUITING

    Nagaoka, Niigata, 940-2085, Japan

  • Investigational Site Number : 3920008

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • Investigational Site Number : 3920009

    RECRUITING

    Tokyo, 160-8582, Japan

  • Investigational Site Number : 3920011

    RECRUITING

    Sapporo, Hokkaido, 060-8543, Japan

  • Investigational Site Number : 4100001

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • Investigational Site Number : 6160002

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Investigational Site Number : 6820001

    RECRUITING

    Riyadh, 12713, Saudi Arabia

  • Investigational Site Number : 6820002

    RECRUITING

    Riyadh, 12372, Saudi Arabia

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Madrid, 28034, Spain

  • Investigational Site Number : 7520001

    RECRUITING

    Huddinge, 141 57, Sweden

  • Investigational Site Number : 7520002

    RECRUITING

    Uppsala, 751 85, Sweden

  • Investigational Site Number : 8260004

    RECRUITING

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Kaiser Permanente - Fontana Medical Center- Site Number : 8400015

    RECRUITING

    Fontana, California, 92335, United States

  • Kanazawa Medical University Hospital-Site Number : 3920002

    RECRUITING

    Kahoku, Uchinada, Ishikawa-ken, 920-0293, Japan

  • Kobe University Hospital-Site Number : 3920010

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

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

    RECRUITING

    Margate, Florida, 33063, United States

  • Malopolskie Badania Kliniczne sp. z. o.o.-Site Number : 6160001

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-002, Poland

  • Massachusetts General Hospital- Site Number : 8400008

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400017

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Ohio State University Wexner Medical Center- Site Number : 8400024

    RECRUITING

    Columbus, Ohio, 43215, United States

  • Paramount Medical Research and Consulting LLC- Site Number : 8400018

    RECRUITING

    Middleburg Heights, Ohio, 44140, United States

  • Primeway Clinical Research- Site Number : 8400019

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • Rabin MC, Outpatient Clinics Building-Site Number : 3760001

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • San Jose Clinical Trials- Site Number : 8400016

    RECRUITING

    San Jose, California, 95128, United States

  • Schiff Center for Liver Diseases- Site Number : 8400010

    RECRUITING

    Miami, Florida, 33136, United States

  • Solace Clinical Research - Tustin- Site Number : 8400020

    RECRUITING

    Tustin, California, 92780, United States

  • Sourasky Rheumatology Dept, Rishonim Building-Site Number : 3760005

    RECRUITING

    Tel Aviv, Central District, 6423906, Israel

  • Stryde Research- Site Number : 8400011

    RECRUITING

    Plano, Texas, 75093, United States

  • The Institute of Medical Science, The University of Tokyo-Site Number : 3920006

    RECRUITING

    Minato-ku, Tokyo, 108-8639, Japan

  • UMCG-Site Number : 5280002

    ACTIVE_NOT_RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Uniwersyteckie Centrum Kliniczne, Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Wczesnych Faz-Site Number : 6160003

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Velocity Clinical Research - Seattle- Site Number : 8400005

    RECRUITING

    Seattle, Washington, 98105, United States

  • Vitalia Medical Research - Margate- Site Number : 8400025

    RECRUITING

    Palm Beach Gardens, Florida, 33410, United States

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