Trial intelligence / Profile preview

Phase 3 randomized double-blind study of rilzabrutinib versus placebo in active IgG4-related disease

2025-521398-15-00Phase 3Authorised

Sponsor
Sanofi
Start
Dec 2025
Modality
Small Molecules
Countries
19
01

Overview

Phase 3, randomised, double-blind trial in IgG4-related disease (IgG4-RD) comparing rilzabrutinib with placebo (2 arms). Primary endpoint: Time to first adjudicated clinical disease flare treated by the investigator during the blinded treatment period. Planned start Dec 2025; status: authorised.

02

Drugs

rilzabrutinib
03

Conditions

IgG4-related disease (IgG4-RD)

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