Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Patients
Trial ID or NCT#
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.
An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in Patients With IgG4-Related Disease
- - 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
- - 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.
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