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

  • End date
    Sep 18, 2024
  • participants needed
  • sponsor
    Principia Biopharma, a Sanofi Company
Updated on 21 October 2022


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.


4 weeks of screening, 12 weeks of main treatment, 12 weeks of cross-over (for GC-only group), 40 weeks of extension treatment and 4-week follow-up.

Condition Immunoglobulin G4 Related Disease
Treatment Glucocorticoids, rilzabrutinib
Clinical Study IdentifierNCT04520451
SponsorPrincipia Biopharma, a Sanofi Company
Last Modified on21 October 2022


Yes No Not Sure

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 weeks

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
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