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A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

NCT07190196 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.

The purpose of this study is to measure time to IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period.

Study details include:

The study duration will be up to 60 weeks, including a 4 to 6-week screening period, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks).

The number of visits will be 16 (plus an optional 9 visits during the OLE).

Conditions

  • Immunoglobulin G4 Related Disease

Interventions

DRUG

Rilzabrutinib

Pharmaceutical form:Tablet-Route of administration:Oral

DRUG

Placebo

Pharmaceutical form:Tablet-Route of administration:Oral

DRUG

Glucocorticoid

Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2028-06-28
Completion
2030-12-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Chile
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Saudi Arabia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT07190196 on ClinicalTrials.gov