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

Trial ID or NCT#

NCT04520451

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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.
    1. Key
Exclusion Criteria:
  1. * 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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Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS
Immunologist, Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)

Contact us to find out if this trial is right for you.

Contact

Angie Aberia
650-723-8516

View on ClinicalTrials.gov