Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
165 participants
INTERVENTIONAL
2025-07-25
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
KPL-387
administered by subcutaneous injection
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.
KPL-387
administered by subcutaneous injection
Placebo
administered by subcutaneous injection
Phase 2 KPL-387 300mg SC q2wk
In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.
KPL-387
administered by subcutaneous injection
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.
KPL-387
administered by subcutaneous injection
Placebo
administered by subcutaneous injection
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.
KPL-387
administered by subcutaneous injection
Phase 3 Placebo SC
RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.
Placebo
administered by subcutaneous injection
Long-Term Extension
Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.
KPL-387
administered by subcutaneous injection
Interventions
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KPL-387
administered by subcutaneous injection
Placebo
administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Kiniksa Pharmaceuticals, GmbH
INDUSTRY
Kiniksa Pharmaceuticals International, plc
INDUSTRY
Responsible Party
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Locations
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Investigational Site 018
Gilbert, Arizona, United States
Investigational Site 008
San Francisco, California, United States
Investigational Site 016
Westminster, Colorado, United States
Investigational Site 001
Columbus, Georgia, United States
Investigational Site 004
Chicago, Illinois, United States
Investigational Site 014
Indianapolis, Indiana, United States
Investigational Site 002
Overland Park, Kansas, United States
Investigational Site 012
Rochester, Minnesota, United States
Investigational Site 015
New York, New York, United States
Investigational Site 009
Cincinnati, Ohio, United States
Investigational Site 003
Cleveland, Ohio, United States
Investigational Site 005
Austin, Texas, United States
Investigational Site 013
Houston, Texas, United States
Investigational Site 006
Richmond, Virginia, United States
Investigational Site 021
Paris, , France
Investigational Site 019
Poitiers, , France
Investigational Site 007
Milan, , Italy
Investigational Site 010
Barcelona, , Spain
Investigational Site 011
Murcia, , Spain
Investigational Site 020
London, , United Kingdom
Investigational Site 017
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2025-521933-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KPL-387-C211
Identifier Type: -
Identifier Source: org_study_id