Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

Conditions

• Pericarditis
• Pericarditis Acute
• Recurrent Pericarditis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• KPL-387 — DRUG
  administered by subcutaneous injection
• Placebo — DRUG
  administered by subcutaneous injection

Study Details

This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.

Key Dates

Start date

Jul 25, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

165 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2 KPL-387 100mg SC q2wk
  In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22.
• Experimental: Phase 2 KPL-387 100mg SC q4wk
  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.
• Experimental: Phase 2 KPL-387 300mg SC q2wk
  In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.
• Experimental: Phase 2 KPL-387 300mg SC q4wk
  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.
• Experimental: Phase 3 KPL-387 SC
  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.
• Placebo Comparator: Phase 3 Placebo SC
  RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.
• Experimental: Long-Term Extension
  Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.

Primary Outcome Measure

Phase 2: Time to Treatment Response by Week 24 [ Time Frame: From Randomization up to Week 24 ]

Central Contacts

• Clinical Project Manager
  781-431-9100
  [email protected]

Locations (27)

Find similar trials in Gilbert, AZ

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