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

NCT04520451

CompletedPhase 2

Sponsor: Principia Biopharma, a Sanofi Company

Conditions: Immunoglobulin G4 Related Disease

Interventions: rilzabrutinib, Glucocorticoids

Countries: United States, Canada, France, Italy, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (9)

Stanford, California, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
New York, New York, United States
Portland, Oregon, United States
Vancouver, Canada
Marseille, France
Milan, Italy
Barcelona, Spain