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KPL-387

Phase 2

Pericarditis | Small molecule | Other |Kiniksa Pharmaceuticals International, plc|Last Updated: Jun 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment165
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07010159Phase 2/3 Study of KPL-387 in Recurrent PericarditisPHASE2 RECRUITING 165 — — Jul 25, 2025Dec 31, 2029Jun 8, 202658 United States, Canada +8
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Study Endpoints
Primary Endpoints
Phase 2: Time to Treatment Response by Week 24
From Randomization up to Week 24
Phase 3: Time to Pericarditis Recurrence
From first administration of study drug in the RW Period
Long-Term Extension: Annualized rate of Pericarditis Recurrence
Up to 24 Months
Secondary Endpoints
Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24
From Randomization up to Week 24
Phase 2: Time to Pain Response by Week 24
From Randomization up to Week 24
Phase 2: Percentage of Days With No or Minimal Pain (Numerical Rating Scale (NRS) ≤ 2) While on KPL-387 Treatment Over Time by Week 24
From Randomization up to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 2 KPL-387 100mg SC q2wkEXPERIMENTALIn 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 q4wkEXPERIMENTALIn 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 q2wkEXPERIMENTALIn Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.
Phase 2 KPL-387 300mg SC q4wkEXPERIMENTALIn 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 SCEXPERIMENTALRun-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 SCPLACEBO_COMPARATORRW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.
Long-Term ExtensionEXPERIMENTALParticipants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.
Interventions
NameTypeDescription
KPL-387DRUGadministered by subcutaneous injection
PlaceboDRUGadministered by subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites58

Key Inclusion Criteria: * Phase 2 and 3: Has a diagnosis of recurrent pericarditis * Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies * Phase 2 and 3: Weighs at least 40 kg * Phase 2: Taking NSAIDS and/or colchicine (in any combination) * Pha...

Countries:United StatesCanadaFranceGermanyGreeceItalyPolandSerbiaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07010159lastUpdatePostDate: changed
LOWJun 8, 2026NCT07010159lastUpdatePostDate: changed
LOWJun 8, 2026NCT07010159lastUpdatePostDate: changed
LOWMay 26, 2026NCT07010159primaryCompletionDate: changed
LOWMay 24, 2026NCT07010159studyFirstPostDate: changed