New pill aims to tame rare inflammatory disease

NCT ID NCT07190196

Recruiting now Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

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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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