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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kaiser Permanente - Fontana Medical Center- Site Number : 8400015
  Fontana, California, United States Recruiting
• University of California Davis Health- Site Number : 8400012
  Sacramento, California, United States Recruiting
• San Jose Clinical Trials- Site Number : 8400016
  San Jose, California, United States Recruiting
• Solace Clinical Research - Tustin- Site Number : 8400020
  Tustin, California, United States Recruiting
• Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002
  Margate, Florida, United States Recruiting
• Vitalia Medical Research - Margate- Site Number : 8400025
  Palm Beach Gardens, Florida, United States Recruiting

+45 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.