Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Principia Biopharma, a Sanofi Company

Collaborator: Massachusetts General Hospital

Stanford Investigator(s):

Intervention(s):

  • Drug: rilzabrutinib
  • Drug: Glucocorticoids

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angie Aberia
650-723-8516
Recruiting