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

• Status: Recruiting
• Trial end date: 2023-12-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Principia Biopharma Inc.; Principia Biopharma, a Sanofi Company
• Collaborator: Massachusetts General Hospital
• Treatments: Glucocorticoids; Prednisolone; Prednisone

Criteria

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.