A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
NCT ID: NCT07190196
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2025-09-26
2030-12-25
Brief Summary
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The purpose of this study is to measure time to 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 4 to 6-week screening period, 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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rilzabrutinib
Rilzabrutinib
Rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Glucocorticoid
Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral
Placebo
Placebo
Placebo
Pharmaceutical form:Tablet-Route of administration:Oral
Glucocorticoid
Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score ≥ 2
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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San Jose Clinical Trials- Site Number : 8400016
San Jose, California, United States
Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002
Margate, Florida, United States
Paramount Medical Research & Consulting, LLC- Site Number : 8400018
Middleburg Heights, Ohio, United States
Stryde Research- Site Number : 8400011
Plano, Texas, United States
Epic Medical Research - Red Oak- Site Number : 8400003
Red Oak, Texas, United States
Velocity Clinical Research - Seattle- Site Number : 8400005
Seattle, Washington, United States
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Concepción, Región del Biobío, Chile
Investigational Site Number : 1560012
Chengdu, , China
Investigational Site Number : 1560010
Hangzhou, , China
Investigational Site Number : 1560011
Wuhan, , China
Investigational Site Number : 2760001
Berlin, , Germany
Investigational Site Number : 2760004
Minden, , Germany
Investigational Site Number : 3760003
Nahariya, , Israel
Investigational Site Number : 3760005
Tel Aviv, , Israel
AOU Meyer IRCCS-Site Number : 3800003
Florence, Tuscany, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi-Site Number : 3800002
Verona, Veneto, Italy
Investigational Site Number : 3920004
Kitakyushu, Fukuoka, Japan
Investigational Site Number : 3920010
Kobe, Hyōgo, Japan
Investigational Site Number : 5280002
Groningen, , Netherlands
Investigational Site Number : 6160003
Gdansk, Pomeranian Voivodeship, Poland
Investigational Site Number : 6160001
Krakow, , Poland
Investigational Site Number : 4100002
Suwon, Gyeonggi-do, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240004
Madrid, , Spain
Investigational Site Number : 7520001
Huddinge, , Sweden
Investigational Site Number : 7520002
Uppsala, , Sweden
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Facility Contacts
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Ilaria Fibbi
Role: primary
Prof. Augusto Vaglio
Role: backup
Dr. Stefano Milleri
Role: primary
Prof. Luca Frulloni
Role: backup
Related Links
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EFC17359 Plain Language Results Summary
Other Identifiers
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U1111-1316-0266
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-521398-15
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC17359
Identifier Type: -
Identifier Source: org_study_id