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

Study Overview

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.

Study details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Immunoglobulin G4 Related Disease
  • Age: 18 Years
  • Gender: All

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 weeks.

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.

Updated on 07 Sep 2023. Study ID: NCT04520451