EFC17359-RILIEF

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  1012463

• Contact name

  Patrick Maury

• Contact email

  patrick.maury@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Eudract number

  2025-521398-15

• Research summary

  IgG4-related disease (IgG4-RD) is a rare condition where the body's immune system attacks multiple organs, causing inflammation and scarring. This can lead to serious organ damage if not treated. Currently, there are limited treatment options available, and most are not specifically approved for IgG4-RD. This study aims to evaluate a new potential treatment for IgG4-RD.
  The research will test a drug called rilzabrutinib (SAR444671) against a placebo in adults with active IgG4-RD. The main goal is to see if rilzabrutinib can extend the time before patients experience a disease flare-up compared to placebo.

  This is a Phase 3 clinical trial, which means it's an advanced stage of testing to determine if the drug is safe and effective. The study will be randomized (participants are assigned to groups by chance) and double-blind (neither patients nor researchers know who's receiving the actual drug or placebo). It will last 52 weeks (1 year) and involve regular check-ups and assessments.

  Participants will be adults diagnosed with active IgG4-RD. The study will measure various aspects of the disease, including how well the treatment controls disease activity, whether it reduces the need for steroids, and its overall safety.

  This research is important because it could lead to a new treatment option for people with IgG4-RD, potentially improving their quality of life and reducing the risk of organ damage.

  For further information, you can contact the study team using the details provided in the full protocol.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  25/LO/0772

• Date of REC Opinion

  5 Jan 2026

• REC opinion

  Further Information Favourable Opinion