Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...