Recruiting
Phase 2
Phase 3

KPL-387

Sponsor:

Kiniksa Pharmaceuticals International, plc

Code:

NCT07010159

Conditions

Pericarditis

Pericarditis Acute

Recurrent Pericarditis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KPL-387

Placebo

Study Details

Brief summary:

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

Conditions

Pericarditis

Pericarditis Acute

Recurrent Pericarditis

Study ID

NCT07010159

Start date

Jul 25, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)
  • Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)

Key Exclusion Criteria:

  • Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
  • Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
  • Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
  • Phase 2 and 3: Has a history of immunodeficiency.
  • Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
  • Phase 2 and 3: Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
  • Phase 2 and 3: Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
  • Phase 2 and 3: Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
  • Phase 2 and 3: Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
  • Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
  • Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.

Study Design

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

KPL-387

administered by subcutaneous injection

Placebo

administered by subcutaneous injection

Primary outcome measure

  • Phase 2: Time to Treatment Response by Week 24 [ Time Frame: From Baseline up to Week 24 ]
  • Phase 3: Time to Pericarditis Recurrence [ Time Frame: From Baseline in the RW Period ]
  • Long-Term Extension: Annualized rate of Pericarditis Recurrence [ Time Frame: Up to 24 Months ]

Central Contacts and Locations

Central contacts

Clinical Project Manager

781-431-9100clinicaltrials@kiniksa.com

Locations

Investigational Site 018

Recruiting

Gilbert, Arizona, United States, 85297

Investigational Site 053

Recruiting

Phoenix, Arizona, United States, 85054

Investigational Site 030

Recruiting

Los Angeles, California, United States, 90048

Investigational Site 008

Recruiting

San Francisco, California, United States, 94158

Investigational Site 044

Recruiting

Santa Monica, California, United States, 90404

Investigational Site 058

Recruiting

Ventura, California, United States, 93003

Investigational Site 016

Recruiting

Westminster, Colorado, United States, 80023

Investigational Site 061

Recruiting

Washington D.C., District of Columbia, United States, 20010

Investigational Site 004

Recruiting

Chicago, Illinois, United States, 60611

Investigational Site 014

Recruiting

Indianapolis, Indiana, United States, 46184

Investigational Site 043

Recruiting

Baltimore, Maryland, United States, 21287

Investigational Site 054

Recruiting

Boston, Massachusetts, United States, 02411

Investigational Site 055

Recruiting

Minneapolis, Minnesota, United States, 55407

Investigational Site 012

Recruiting

Rochester, Minnesota, United States, 55905

Investigational Site 050

Recruiting

Kansas City, Missouri, United States, 64111

Investigational Site 046

Recruiting

Kansas City, Missouri, United States, 66160

Investigational Site 062

Recruiting

St Louis, Missouri, United States, 63130

Investigational Site 015

Recruiting

New York, New York, United States, 10016

Investigational Site 022

Recruiting

New York, New York, United States, 10032

Investigational Site 009

Recruiting

Cincinnati, Ohio, United States, 45219

Investigational Site 003

Recruiting

Cleveland, Ohio, United States, 44195

Investigational Site 005

Recruiting

Austin, Texas, United States, 78705

Investigational Site 013

Recruiting

Houston, Texas, United States, 77030

Investigational Site 042

Recruiting

Burlington, Vermont, United States, 05401

Investigational Site 006

Recruiting

Charlottesville, Virginia, United States, 22903

Investigational Site 023

Recruiting

Norfolk, Virginia, United States, 23507

Investigational Site 045

Recruiting

Richmond, Virginia, United States, 23284

Investigational Site 027

Recruiting

Ottawa, Ontario, Canada, K1N 6N5

More Information

Sponsor

Kiniksa Pharmaceuticals International, plc

Last update posted

Aug 26, 2026

Last verified

Jul, 2026

Keywords

  • Recurrence
  • Recurrent
  • Recurrent Pericarditis
  • KPL-387

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Kiniksa Pharmaceuticals International, plc on 2026-08-26.