Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Patients


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Trial ID: NCT04520451


This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocorticoids and (2) Active Comparator: glucocorticoids only.

Official Title

An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in Patients With IgG4-Related Disease

Stanford Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS

Assistant Professor of Medicine (Immunology and Rheumatology)

Reena Thomas, MD PhD
Reena Thomas, MD PhD

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery


Key Inclusion Criteria:

   - Be male or female with age ≥18 years.

   - Have a clinical diagnosis of IgG4-RD.

   - Be willing to taper off an equivalent prednisone dose of between 20-40 mg/day in 2

Key Exclusion Criteria:

   - Currently or within 6 months of screening taking rituximab, other B-cell depleting
   agents, or alkylating agents unless B cell concentrations have been demonstrated by
   flow cytometry to return to normal values (defined as 5 cells per cubic mm).

   - History of solid organ transplant

   - Positive at Screening for HIV, hepatitis B, hepatitis C, or TB

   - Female patients who are pregnant or nursing.

   - NOTE: Other Inclusion/Exclusion criteria may apply.


drug: rilzabrutinib

drug: Glucocorticoids


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angie Aberia