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KPL-387 · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Posology KPL-387 | EXPERIMENTAL | In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16. |
| Long-Term Extension | EXPERIMENTAL | Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first. |
| Phase 2 KPL-387 100mg SC q2wk | EXPERIMENTAL | In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22. |
| Phase 2 KPL-387 100mg SC q4wk | EXPERIMENTAL | In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment. |
| Phase 2 KPL-387 300mg SC q2wk | EXPERIMENTAL | In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22. |
| Phase 2 KPL-387 300mg SC q4wk | EXPERIMENTAL | In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment. |
| Phase 3 KPL-387 SC | EXPERIMENTAL | Run-In (RI) Period: participants receive single-blind KPL-387 Randomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387. |
| Phase 3 Placebo SC | PLACEBO_COMPARATOR | RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo. |
| Name | Type | Description |
|---|---|---|
| KPL-387 | DRUG | administered by subcutaneous injection |
| Placebo | DRUG | administered by subcutaneous injection |
Key Inclusion Criteria: * Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline) * Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis ...
KPL-387 is an investigational small molecule being developed for the treatment of pericarditis, including recurrent pericarditis. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in patients with recurrent pericarditis to evaluate its efficacy and safety.
KPL-387 is being developed by Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol KNSA. The company is conducting clinical trials to evaluate the drug's potential in treating recurrent pericarditis.
KPL-387 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted orphan drug designation by the FDA for the treatment of pericarditis, reflecting its potential role in addressing this condition.
KPL-387 is being studied in two Phase 2 clinical trials. The first, NCT07010159, is a Phase 2/3 study evaluating the efficacy and safety of KPL-387 in participants with recurrent pericarditis, with an enrollment of 325. The second, NCT07288216, is a study on transitioning to KPL-387 monotherapy dosing and administration, with an enrollment of 80.
No, KPL-387 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The FDA has granted orphan drug designation for KPL-387, which provides certain development incentives, but the drug has not yet completed clinical trials or received marketing approval.