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

Conditions

• Immunoglobulin G4 Related Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rilzabrutinib — DRUG
  Pharmaceutical form:Tablet-Route of administration:Oral
• Placebo — DRUG
  Pharmaceutical form:Tablet-Route of administration:Oral
• Glucocorticoid — DRUG
  Pharmaceutical form:Tablet, solution, suspension formulations according to local standard practices-Route of administration:Oral

Study Details

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).

Key Dates

Start date

Sep 26, 2025

Status verified

Jun 2026

Primary completion

Jun 28, 2028

Completion

Dec 25, 2030

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rilzabrutinib
  Rilzabrutinib
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period [ Time Frame: Until Week 52 ]

Central Contacts

• Trial Transparency email recommended (Toll free for US & Canada)
  800-633-1610
  [email protected]

Locations (17)

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