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Rilzabrutinib versus placebo for adults with IgG4-related disease (52-week treatment)

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

Phase 3 Interventional Sanofi · NCT07190196

This 52-week study will try rilzabrutinib tablets to see if they prevent disease flares and better control symptoms in adults with active IgG4-related disease compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsrilzabrutinib
Locations68 sites (San Jose, California and 67 other locations)
Trial IDNCT07190196 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled, two-arm trial testing rilzabrutinib tablets in adults with active IgG4-related disease. The main outcome is time to clinical disease flare, with additional endpoints including flare-free rate, disease activity control, glucocorticoid (GC) rescue use, and safety measures over a 52-week blinded period. Eligible participants must be adults with an adjudicated IgG4-RD diagnosis, active disease on a stable GC dose, and agree to taper GC after starting the investigational product; repeated imaging (CT, MRI, PET, or ultrasound) is required per protocol. The total participation is up to 60 weeks including screening and follow-up, with an optional open-label extension of 108 weeks.

Who should consider this trial

Good fit: Adults aged 18 and older with an adjudicated diagnosis of IgG4-related disease, active disease (IgG4-RD Responder Index ≥2) while on a stable glucocorticoid dose, and willingness to taper steroids and undergo protocol imaging are ideal candidates.

Not a fit: Patients without active disease, those with only lymph node involvement, children, or anyone unwilling/unable to taper glucocorticoids or complete required imaging and clinic visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, rilzabrutinib could extend time between flares, reduce steroid dependence, and improve long-term disease control for adults with IgG4-RD.

How similar studies have performed: Early-phase studies and research of BTK inhibitors including rilzabrutinib in other autoimmune conditions have shown signals of activity, but Phase 3 evidence specifically in IgG4-RD is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have an adjudicated clinical diagnosis of IgG4-RD
* 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:

* Meet any Step 2 Exclusion criteria from the 2019 ACR/EULAR classification criteria for IgG4-RD.
* History of retroperitoneal fibrosis, sclerosing mesenteritis, fibrosing mediastinitis, or other overwhelmingly fibrotic expression of IgG4-RD that is the sole disease manifestation.
* 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.

Where this trial is running

San Jose, California and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Immunoglobulin G4 Related Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.