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 Baker
Matthew Baker
Immunologist, Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)
Reena Thomas, MD PhD
Reena Thomas, MD PhD
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

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

Contact

Angie Aberia
650-723-8516

View on ClinicalTrials.gov