Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07190196 | A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease | PHASE3 | RECRUITING | 124 | — | — | Sep 26, 2025 | Dec 25, 2030 | Jun 2, 2026 | 76 | United States, Argentina +17 |
| NCT04520451 | Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants | PHASE2 | COMPLETED | 27 | — | — | Aug 22, 2020 | Oct 15, 2024 | Oct 14, 2025 | 9 | United States, Canada +3 |
The Adjudication Committee will include internationally recognized independent experts in diagnosis and management of patients with IgG4-RD, blinded to participant, investigator, and site identifiers
Disease flare is defined as an increase in IgG4-RD responder index (RI) \>2 or initiation of rescue treatment.
| Arm | Type | Description |
|---|---|---|
| Rilzabrutinib | EXPERIMENTAL | Rilzabrutinib |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Rilzabrutinib + glucocorticoids | EXPERIMENTAL | Rilzabrutinib tablets, 400 mg twice daily from Week 0 to Week 12 plus glucocorticoids (20 to 40 mg/day prednisone equivalent tapered to 0 mg/day within 2 weeks on study) |
| Glucocorticoids | ACTIVE_COMPARATOR | Glucocorticoids (20 to 40 mg/day prednisone equivalent tapered to 0 mg/day within 12 weeks on study) |
| Name | Type | Description |
|---|---|---|
| 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 |
| Glucocorticoids | DRUG | oral tablet or capsule |
Inclusion Criteria: * Participants must have an adjudicated clinical diagnosis of IgG4-RD * Participants meeting Step 1 Entry criteria of 2019 ACR/EULAR classification criteria for IgG4-RD and Total inclusion points are ≥20 * Participants with active disease at screening in at least one organ syste...