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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 by Kiniksa Pharmaceuticals International, plc for the treatment of pericarditis and recurrent pericarditis. It is in Phase 2 clinical development and has received an orphan drug designation from the FDA. It is not yet approved for any indication.
KPL-387 is being studied for the treatment of pericarditis and recurrent pericarditis, inflammatory conditions affecting the sac surrounding the heart. Clinical development is focused on adults 18 years and older. The program includes a Phase 2/3 study evaluating efficacy and safety in participants with recurrent pericarditis.
KPL-387 targets IL-1R1, the type 1 interleukin-1 receptor. By binding this receptor, the small molecule is designed to block interleukin-1 signaling, a pathway involved in the inflammation that drives pericarditis and recurrent pericarditis. Targeting IL-1R1 is the mechanism under investigation in the ongoing clinical program.
KPL-387 is being developed by Kiniksa Pharmaceuticals International, plc, which trades on the Nasdaq under the ticker KNSA. Kiniksa is the sponsor of the clinical program studying the drug in pericarditis and recurrent pericarditis.
KPL-387 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The program includes a Phase 2/3 study in recurrent pericarditis and a Phase 2 monotherapy dosing and administration study, both currently recruiting participants.
KPL-387 is being evaluated in two recruiting studies. NCT07010159 is a Phase 2/3 study of participants with recurrent pericarditis, with planned enrollment of 325. NCT07288216 is a Phase 2 transition to KPL-387 monotherapy dosing and administration study, with planned enrollment of 120. Both are randomized, double-blind, and placebo-controlled.