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

NCT04520451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Immunoglobulin G4 Related Disease

Interventions

DRUG

rilzabrutinib

oral tablet

DRUG

Glucocorticoids

oral tablet or capsule

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Principia Biopharma, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-22
Primary Completion
2024-10-15
Completion
2024-10-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520451 on ClinicalTrials.gov