A Phase 3 interventional study of Rilzabrutinib and Placebo in Immunoglobulin G4 Related Disease, sponsored by Sanofi. Recruiting at 95 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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).
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
This study's planned enrollment of 124 is above the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Browse Immunoglobulin G4-Related Disease studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rilzabrutinib
Drug: Rilzabrutinib · Drug: Glucocorticoid
Placebo
Drug: Placebo · Drug: Glucocorticoid
Pharmaceutical form:Tablet-Route of administration:Oral
Also known as: SAR444671
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral
Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period
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
Time frame: Until Week 52
Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids and immunomodulators
Time frame: At Week 52
Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids
Time frame: At Week 52
Annualized rate of clinical disease flares
Time frame: At Week 52
Change in IgG4-RD RI total activity scores from baseline to Week 52
Time frame: From baseline to Week 52
Proportion of participants in complete remission at Week 52
Defined by an IgG4-RD RI total activity score = 0 or absence of evident disease activity assessed by the Investigator
Time frame: At Week 52
Percent change in IgG4-RD RI total activity scores from baseline to Week 52
Time frame: From baseline to Week 52
Change in IgG4-RD RI total activity scores from baseline to Week 12
Time frame: From baseline to Week 12
Percent change in IgG4-RD RI total activity scores from baseline at Week 12
Time frame: From baseline to Week 12
Proportion of participants with reduction of ≥2 points from the baseline IgG4-RD RI total activity score
Time frame: At Week 12, Week 24, and Week 52
Cumulative glucocorticoid dose for treatment of IgG4-RD
Time frame: At Week 52
Proportion of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
Time frame: Until Week 160
Proportion of participants with TEAEs, AESIs, SAEs in the Safety Population
Time frame: Until Week 160
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Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rilzabrutinib
Immunoglobulin G4-Related Disease →