A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
Public ClinicalTrials.gov record NCT07190196. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07190196
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 26, 2025 (Actual)
- Primary completion
- Jun 28, 2028 (Estimated)
- Completion
- Dec 25, 2030 (Estimated)
- Last update posted
- Oct 20, 2026
2025 – 2030
United States locations
- U.S. sites
- 21
- U.S. states
- 11
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente - Fontana Medical Center- Site Number : 8400015 | Fontana | California | 92335 | Recruiting |
| University of California Davis Health- Site Number : 8400012 | Sacramento | California | 95817 | Recruiting |
| San Jose Clinical Trials- Site Number : 8400016 | San Jose | California | 95128 | Recruiting |
| Solace Clinical Research - Tustin- Site Number : 8400020 | Tustin | California | 92780 | Recruiting |
| Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002 | Margate | Florida | 33063 | Recruiting |
| Vitalia Medical Research - Margate- Site Number : 8400025 | Palm Beach Gardens | Florida | 33410 | Recruiting |
| Tampa General Hospital - Tampa - General Circle- Site Number : 8400027 | Tampa | Florida | 33606 | Recruiting |
| Emory University School of Medicine - Atlanta- Site Number : 8400013 | Atlanta | Georgia | 30322 | Recruiting |
| Primeway Clinical Research- Site Number : 8400019 | Fayetteville | Georgia | 30214 | Recruiting |
| Massachusetts General Hospital- Site Number : 8400008 | Boston | Massachusetts | 02114 | Recruiting |
| Henry Ford Hospital- Site Number : 8400009 | Detroit | Michigan | 48202 | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400017 | Rochester | Minnesota | 55905 | Recruiting |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400014 | New York | New York | 10029 | Recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400035 | Charlotte | North Carolina | 28207 | Recruiting |
| Cleveland Clinic - Cleveland- Site Number : 8400001 | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State University Wexner Medical Center- Site Number : 8400024 | Columbus | Ohio | 43215 | Recruiting |
| Paramount Medical Research and Consulting LLC- Site Number : 8400018 | Middleburg Heights | Ohio | 44140 | Recruiting |
| Stryde Research- Site Number : 8400011 | Plano | Texas | 75093 | Recruiting |
| Epic Medical Research - Red Oak- Site Number : 8400003 | Red Oak | Texas | 75154 | Recruiting |
| Digestive Health Research of North Texas- Site Number : 8400021 | Wichita Falls | Texas | 76301 | Recruiting |
| Velocity Clinical Research - Seattle- Site Number : 8400005 | Seattle | Washington | 98105 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07190196, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07190196 live on ClinicalTrials.gov.