Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387
Kiniksa Pharmaceuticals International, plc · with Kiniksa Pharmaceuticals, GmbH · NCT07010159
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 325
- US sites recruiting
- 30
- Study start
- July 25, 2025
- Record last updated
- October 19, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Being studied: KPL-387; Placebo
Conditions: Pericarditis; Pericarditis Acute; Recurrent Pericarditis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Investigational Site 018
Gilbert, AZ 85297
Investigational Site 053
Phoenix, AZ 85054
Investigational Site 064
La Jolla, CA 92037
Investigational Site 030
Los Angeles, CA 90048
Investigational Site 008
San Francisco, CA 94158
Investigational Site 044
Santa Monica, CA 90404
Investigational Site 058
Ventura, CA 93003
Investigational Site 016
Westminster, CO 80023
Investigational Site 061
Washington D.C., DC 20010
Investigational Site 004
Chicago, IL 60611
Investigational Site 014
Indianapolis, IN 46184
Investigational Site 043
Baltimore, MD 21287
Investigational Site 054
Boston, MA 02411
Investigational Site 055
Minneapolis, MN 55407
Investigational Site 012
Rochester, MN 55905
Investigational Site 050
Kansas City, MO 64111
Investigational Site 046
Kansas City, MO 66160
Investigational Site 062
St Louis, MO 63130
Investigational Site 015
New York, NY 10016
Investigational Site 022
New York, NY 10032
Investigational Site 009
Cincinnati, OH 45219
Investigational Site 003
Cleveland, OH 44195
Investigational Site 005
Austin, TX 78705
Investigational Site 066
Houston, TX 77004
Investigational Site 013
Houston, TX 77030
Investigational Site 042
Burlington, VT 05401
Investigational Site 006
Charlottesville, VA 22903
Investigational Site 023
Norfolk, VA 23507
Investigational Site 045
Richmond, VA 23284
Investigational Site 065
Seattle, WA 98122
Study contacts (from the official record)
- Clinical Project Manager · 781-431-9100 · clinicaltrials@kiniksa.com