Trial Search Results

Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease Patients

PRN1008-017 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: PRN1008 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:

   1. Be male or female with age ≥ 18 years.

   2. Have a clinical diagnosis of IgG4-RD

Key Exclusion Criteria:

   1. 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).

   2. History of solid organ transplant

   3. Positive at Screening for HIV, hepatitis B, hepatitis C, or TB

   4. Female patients who are pregnant or nursing.

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
Recruiting