ClinicalTrials.gov record NCT07190196

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old and older
SexAll
LocationArgentina, Belgium, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, quadruple-masked Phase 3 trial compares oral rilzabrutinib (SAR444671) with matching placebo in adults diagnosed with Immunoglobulin G4 Related Disease. The main blinded treatment period is 52 weeks (plus screening and a short follow-up), with an optional 108-week open-label extension. The primary measure is time to an adjudicated clinical disease flare; other outcomes include flare rates, changes in disease activity scores, glucocorticoid use, and safety.

What it is studying. The study tests whether oral rilzabrutinib (SAR444671) changes the time to a clinically adjudicated IgG4‑RD disease flare compared with placebo during a 52‑week blinded treatment period. It also assesses flare-free rates, disease activity by IgG4‑RD Responder Index scores, use of glucocorticoids, and safety measures (treatment-emergent adverse events, laboratory abnormalities, and ECG findings).

What the researchers hope to learn. To measure time to first adjudicated IgG4‑RD clinical disease flare through Week 52; to compare flare-free rates, annualized flare rates, and changes in IgG4‑RD Responder Index scores; to assess proportions in complete remission and cumulative glucocorticoid dose; and to characterize safety (treatment-emergent adverse events, adverse events of special interest, serious adverse events, laboratory and ECG abnormalities) through the study period.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Rilzabrutinib
  • Placebo
  • Glucocorticoid

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participants must have a clinical diagnosis of IgG4-RD confirmed by the Adjudication Committee.
  • 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 in at least 1 organ system, excluding lymph nodes, with active disease defined by an IgG4-RD Responder Index organ/site activity score ≥2 based on the manifestations of disease activity in the last 28 days.
  • 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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned to take oral rilzabrutinib tablets or matching placebo during a 52‑week blinded treatment period; glucocorticoid tablets may also be used and participants are expected to be willing to taper glucocorticoids after starting study treatment. The study begins with a 4–6 week screening, includes about 16 visits during the 52‑week period, a 2‑week follow‑up, and an optional open‑label extension of up to 108 weeks with up to nine additional visits. At visits you will have blood tests and electrocardiograms (ECGs), repeat imaging as needed to assess IgG4‑RD (CT, MRI, PET, or ultrasound), and clinical assessments of disease activity; an independent Adjudication Committee will review clinical flares during the blinded period.

How the study is structured. Adults are randomly assigned to one of two parallel groups: rilzabrutinib tablets plus glucocorticoid management, or matching placebo plus glucocorticoid management. The study is quadruple-masked (participant, care provider, investigator, and outcomes assessors are blinded) and follows participants through a 52‑week blinded treatment period after screening, with a 2‑week follow-up and an optional 108‑week open‑label extension. Assessments include scheduled clinic visits, disease activity scoring, safety monitoring, and adjudication of flares by an independent committee.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in Argentina, Belgium, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 26, 2025
Primary completion
Jun 28, 2028 (estimated)
Study completion
Dec 25, 2030 (estimated)
Target enrollment
124 participants (estimated)
Last updated on registry
Sep 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Sanofi

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (92)

  • Kaiser Permanente - Fontana Medical Center- Site Number : 8400015Recruiting

    Fontana, California, 92335 · United States

  • University of California Davis Health- Site Number : 8400012Recruiting

    Sacramento, California, 95817 · United States

  • San Jose Clinical Trials- Site Number : 8400016Recruiting

    San Jose, California, 95128 · United States

  • Solace Clinical Research - Tustin- Site Number : 8400020Recruiting

    Tustin, California, 92780 · United States

  • Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002Recruiting

    Margate, Florida, 33063 · United States

  • Vitalia Medical Research - Margate- Site Number : 8400025Recruiting

    Palm Beach Gardens, Florida, 33410 · United States

  • Emory University School of Medicine - Atlanta- Site Number : 8400013Recruiting

    Atlanta, Georgia, 30322 · United States

  • Primeway Clinical Research- Site Number : 8400019Recruiting

    Fayetteville, Georgia, 30214 · United States

  • Massachusetts General Hospital- Site Number : 8400008Recruiting

    Boston, Massachusetts, 02114 · United States

  • Henry Ford Hospital- Site Number : 8400009Recruiting

    Detroit, Michigan, 48202 · United States

Terms used on this page · explanations by MedicalUpdates.ai

parallel group
Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
treatment-emergent adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Screening period
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
stable dose
A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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