MinorEligibility criteria expanded, about 17 words
Secondary endpoints: 11 to 12
v17
MinorTrial sites expanded: 76 → 79 locationsv16
MinorStudy sites: 74 to 76v15
MinorTrial sites expanded: 68 → 74 locationsv14
MinorStudy sites: 66 to 68v13
MinorTrial sites expanded: 58 → 66 locationsv12
MinorStudy sites: 49 to 58v11
MinorStudy sites: 40 to 49v10
MinorStudy sites: 32 to 40v9
MinorStudy sites: 25 to 32
Secondary endpoints revised (11)
v8
MinorStudy sites: 13 to 25v7
MinorStudy sites: 11 to 13v6
MinorStudy sites: 7 to 11v5
MinorStudy sites: 6 to 7v4
MinorStudy sites revised (6)v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 6
Start date changed from estimate of Sep 18, 2025 to Sep 26, 2025
v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 adjudicated 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 Screening period of 4 to 6 weeks, 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).