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.
Principia Biopharma, a Sanofi Company
Collaborator: Massachusetts General Hospital
- Drug: rilzabrutinib
- Drug: Glucocorticoids
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