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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06708299 | CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) | PHASE3 | RECRUITING | 110 | — | — | Apr 7, 2025 | Oct 21, 2026 | Jun 3, 2026 | 27 | United States, Canada +2 |
| NCT05494788 | Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot) | PHASE2 | COMPLETED | 27 | — | — | Jan 9, 2023 | Sep 6, 2024 | Oct 20, 2025 | 8 | United States |
proportions of patients free from a new episode of recurrent pericarditis\* from the timepoint of stopping the IL-1 blocker to Week 24
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
| Arm | Type | Description |
|---|---|---|
| CardiolRx | ACTIVE_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight CardiolRx b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight CardiolRx b.i.d. |
| Placebo | PLACEBO_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight matching placebo b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight matching placebo b.i.d. |
| Name | Type | Description |
|---|---|---|
| CardiolRx | DRUG | The intervention will be administered orally (via syringe) with food twice daily. |
Inclusion Criteria: 1. Patients 18 years of age or older 2. A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as: * treatment with an IL-1 blocker for at least 12 months, * free of...