Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Principia Biopharma, a Sanofi Company
With
Massachusetts General Hospital
4 weeks of screening, 12 weeks of main treatment, 12 weeks of cross-over (for GC-only group), 40 weeks of extension treatment and 4-week follow-up.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants