Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
Study on Investigational Treatment with Steroids in IgG4-Related Disease
Study Overview
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.
Study Details
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Immunoglobulin G4 Related Disease
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Age: 18 years or above
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Gender: All
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.
This study investigates the effects of an investigational medication in combination with glucocorticoids for individuals with IgG4-related disease (IgG4-RD). The study consists of two arms: one receiving the investigational medication with glucocorticoids and the other receiving glucocorticoids only.
Participants in the study will undergo several procedures, including a screening phase and various treatment phases. The main treatment phase lasts for 12 weeks, followed by a cross-over phase for those initially receiving only glucocorticoids. The study also includes an extension treatment phase and a follow-up period to monitor participants' health and response to the treatments.
- Who can participate: Participants must be 18 years or older with a clinical diagnosis of IgG4-RD. They should be willing to taper off a prednisone dose of 20-40 mg/day within 2 weeks. Individuals with recent use of certain medications or conditions like organ transplant or positive tests for specific infections are excluded.
- Study details: Participants will be assigned to one of two study arms. One arm involves taking an investigational medication along with glucocorticoids, while the other arm involves glucocorticoids only. Participants will undergo regular health assessments and follow-ups to evaluate the treatment's effects.
- Study timelines: The study will last 72 weeks.
