Approval Probability
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ML Risk
KPL-914 · 1 trial · 1 indication
The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
Baseline is defined as the last non-missing assessment prior to the first study drug administration.
The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be"). Baseline is defined as the last non-missing assessment prior to the first study drug administration.
| Arm | Type | Description |
|---|---|---|
| KPL-914: Part 1 Participants | EXPERIMENTAL | Part 1 enrolls symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein \[CRP\] \> 1mg/dL). |
| KPL-914: Part 2 Participants | EXPERIMENTAL | Part 2 enrolls symptomatic participants with RIP with CRP ≤1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab. |
| KPL-914: Part 3 Participants | EXPERIMENTAL | Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. |
| KPL-914: Part 4 Participants | EXPERIMENTAL | Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP \> 1mg/dL). |
| KPL-914: Part 5 Participants | EXPERIMENTAL | Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. |
| Name | Type | Description |
|---|---|---|
| KPL-914 | DRUG | KPL-914 (rilonacept) will be provided in its commercially available formulation as a lyophilized powder to be reconstituted for SC administration. Adult participants (≥ 18 years of age) KPL-914 will be administered as an initial loading dose of 320 mg SC, delivered as 2 subcutaneous injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Pediatric participants (6 to \<18 years of age) KPL-914 will be administered with an initial loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 2 subcutaneous injections of 2.2 mg/kg each with a maximum single-injection volume of 2 mL. Participants considered to be 'treatment responders' will be offered participation in an optional 18-week extension period (EP) in which KPL-914 can be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
Inclusion Criteria for All Participants: * Has given consent (or assent, if applicable) and signed an Informed Consent Form (ICF) (or informed assent form, if applicable). * Male or female, of any ethnic origin. * 6 to 75 years of age, inclusive. * If used, has received non-steroidal anti-inflammat...
KPL-914 is an investigational small molecule being studied for the treatment of recurrent pericarditis, a condition characterized by inflammation of the pericardium. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
KPL-914 is being developed by Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol KNSA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with recurrent pericarditis.
KPL-914 is in Phase 2 clinical development. A pilot study of the drug in recurrent pericarditis has been completed, but the drug remains investigational and is not yet approved for commercial use.
KPL-914 has been studied in a Phase 2 clinical trial with the identifier NCT03980522, titled 'A Pilot Study of KPL-914 in Recurrent Pericarditis.' This trial, which enrolled 26 participants in the United States, has been completed.
KPL-914 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for recurrent pericarditis. The completed pilot study represents early-stage research, and the drug has not yet received regulatory approval.