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

Study on IgG4-Related Disease with Investigational Medication and Glucocorticoids

Not Recruiting
18 years or above
All
Phase 2
27 participants needed

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
  • Age: 18 years or above
  • 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.

Updated on 25 Mar 2025. Study ID: NCT04520451

This study investigates the effects of an investigational medication combined with glucocorticoids compared to glucocorticoids alone in patients with IgG4-related disease. IgG4-related disease is a condition where the immune system causes inflammation in different parts of the body, leading to swelling and organ damage.

Participants will be divided into two study arms. One group will receive the investigational medication along with glucocorticoids, while the other group will receive glucocorticoids only. After the main treatment period, those in the glucocorticoid-only group will have the opportunity to switch to the investigational medication.

  • Who can participate: Adults aged 18 and older with IgG4-related disease can participate. Participants must be willing to reduce their glucocorticoid dose and meet certain health criteria.
  • Study details: Participants will receive either an investigational medication with glucocorticoids or glucocorticoids alone. The study includes a crossover period for those initially receiving glucocorticoids only.
  • Study Timelines: The study will last 72 weeks.