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NCT07190196 · ClinicalTrials.gov registry record · Phase 3
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
A Phase 3 study of Immunoglobulin G4 Related Disease, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT07190196: Recruiting Phase 3 study of Immunoglobulin G4 Related Disease, sponsored by Sanofi.
NCT07190196 is a Phase 3 study of Immunoglobulin G4 Related Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 124 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07190196, a Phase 3 study of Immunoglobulin G4 Related Disease, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study 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 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).
Primary Outcome
The Adjudication Committee will include internationally recognized independent experts in diagnosis and management of patients with IgG4-RD, blinded to participant, investigator, and site identifiers
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rilzabrutinib
- DRUG Glucocorticoid
Study Locations (20)
Florida
- Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002 - Margate
- Schiff Center for Liver Diseases/University of Miami- Site Number : 8400010 - Miami
- Vitalia Medical Research - Margate- Site Number : 8400025 - Palm Beach Gardens
Texas
- Stryde Research- Site Number : 8400011 - Plano
- Epic Medical Research - Red Oak- Site Number : 8400003 - Red Oak
- Digestive Health Research of North Texas- Site Number : 8400021 - Wichita Falls
California
- San Jose Clinical Trials- Site Number : 8400016 - San Jose
- Solace Clinical Research - Tustin- Site Number : 8400020 - Tustin
Ohio
- Cleveland Clinic - Cleveland- Site Number : 8400001 - Cleveland
- Paramount Medical Research and Consulting LLC- Site Number : 8400018 - Middleburg Heights
Other
- Investigational Site Number : 0320004 - Buenos Aires
- Investigational Site Number : 0560001 - Leuven
Reg Metropolitana de Santiago
- Centro de estudios G y C-Site Number : 1520003 - Santiago
- Investigational Site Number : 1520006 - Santiago
Georgia
- Primeway Clinical Research- Site Number : 8400019 - Fayetteville
Minnesota
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400017 - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2030-12-25 |
| Phase | Phase 3 |
What NCT07190196 shows while recruiting
NCT07190196 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Immunoglobulin G4 Related Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07190196 names 20 study sites across 12 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT07190196 about?
NCT07190196 is a clinical study titled "A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease". 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 IgG4-RD clinical disease flare, a...
What is the current status of trial NCT07190196?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2025-09-26. Estimated completion is 2030-12-25.
What conditions does trial NCT07190196 study?
This clinical trial studies the following conditions: Immunoglobulin G4 Related Disease.
What interventions are being tested in trial NCT07190196?
The interventions under investigation include: Placebo (DRUG), Rilzabrutinib (DRUG), Glucocorticoid (DRUG).
Who is sponsoring clinical trial NCT07190196?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07190196 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07190196's enrollment target sits among peer trials
124 1611th of 2000 higher than 386 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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