Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rilonacept · 1 trial · 1 indication
Time to pericarditis recurrence (from randomization to 1st recurrence). Kaplan-Meier. Clinical Events Committee (CEC)-confirmed recurrences used for primary analysis. Recurrence defined as recurrence typical pericarditis pain with supportive objective evidence. CEC-adjudicated recurrences defined as:1) Re-appearance/worsening pericarditis pain (1 NRS ≥ 4) AND elevated CRP (≥1.0 mg/dL) on same day/separated by ≤ 7 days OR 2) Re-appearance/worsening pericarditis pain (1 NRS ≥ 4) AND abnormal CRP (\> 0.5 mg/dL) on same day/separated by ≤ 7 days AND 1 supportive evidence OR 3) Re-appearance/worsening pericarditis pain (no NRS ≥ 4) AND elevated CRP (≥ 1.0 mg/dL) not attributable to other causes AND 1 supportive evidence. Supportive evidence: White blood cell count \> upper limit normal, fever \> 38C, pericardial rub, electrocardiogram changes consistent with pericarditis, new/worsening pericardial effusion (echocardiogram), new/worsening pericardial inflammation (magnetic resonance imaging).
| Arm | Type | Description |
|---|---|---|
| Rilonacept | EXPERIMENTAL | RI period: single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants) SC, followed by 160 mg (or 2.2 mg/kg in pediatric participants) injections once weekly. RW period: eligible participants randomized to double-blinded administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly. Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL \[either on the same day or separated by no more than 7 days\]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept \[or 4.4 mg/kg for pediatric participants\]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection. LTE period: open-label administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly. |
| Placebo | PLACEBO_COMPARATOR | RI period: single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants) SC, followed by 160 mg (or 2.2 mg/kg in pediatric participants) injections once weekly. RW period: eligible participants randomized to placebo SC injections once weekly. Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point NRS and have 1 CRP value ≥ 1 mg/dL \[either on the same day or separated by no more than 7 days\]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept \[or 4.4 mg/kg for pediatric participants\]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection. LTE period: open-label administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly. |
| Name | Type | Description |
|---|---|---|
| Rilonacept | DRUG | Rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and \<18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) injections once weekly |
| Placebo | DRUG | Placebo SC injections once weekly |
Key Inclusion Criteria: 1. Male or female aged 12 or older 2. Has a diagnosis of recurrent pericarditis 3. Must provide Informed Consent 4. Presents with at least the third episode of pericarditis during screening. 5. Has received nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/...
Rilonacept is used for recurrent pericarditis, a condition involving repeated inflammation of the pericardium, the sac surrounding the heart. It is being developed as a treatment for this indication and is currently in Phase 3 clinical development.
Rilonacept is being developed by Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol KNSA.
Rilonacept is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial for recurrent pericarditis has been completed.
Rilonacept has one completed Phase 3 clinical trial, identified as NCT03737110, which assessed its efficacy and safety in participants with recurrent pericarditis. The trial enrolled 86 participants and was conducted in the United States, Australia, Israel, and Italy.
Yes, Rilonacept is classified as a small molecule therapeutic. It is being studied for the treatment of recurrent pericarditis, a cardiovascular condition.