Clinical Trials in France / NCT07010159
Recruiting
Phase 2/3
Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387
NCT07010159 · tracked via the Priya Life Science France tracker
Condition(s) studied
PericarditisPericarditis AcuteRecurrent Pericarditis
Investigational drug(s) / intervention(s)
KPL-387 →Placebo
KPL-387: administered by subcutaneous injection
Placebo: administered by subcutaneous injection
Study summary
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Eligibility
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.
Primary outcome measure(s)
- Phase 2: Time to Treatment Response by Week 24 — From Baseline up to Week 24
- Phase 3: Time to Pericarditis Recurrence — From Baseline in the RW Period
- Long-Term Extension: Annualized rate of Pericarditis Recurrence — Up to 24 Months
Trial sites (66)
| Facility | City | Region | Status |
|---|---|---|---|
| Investigational Site 018 | Gilbert | Arizona | Recruiting |
| Investigational Site 053 | Phoenix | Arizona | Recruiting |
| Investigational Site 064 | La Jolla | California | Recruiting |
| Investigational Site 030 | Los Angeles | California | Recruiting |
| Investigational Site 008 | San Francisco | California | Recruiting |
| Investigational Site 044 | Santa Monica | California | Recruiting |
| Investigational Site 058 | Ventura | California | Recruiting |
| Investigational Site 016 | Westminster | Colorado | Recruiting |
| Investigational Site 061 | Washington D.C. | District of Columbia | Recruiting |
| Investigational Site 001 | Columbus | Georgia | Withdrawn |
| Investigational Site 004 | Chicago | Illinois | Recruiting |
| Investigational Site 014 | Indianapolis | Indiana | Recruiting |
| Investigational Site 002 | Overland Park | Kansas | Withdrawn |
| Investigational Site 043 | Baltimore | Maryland | Recruiting |
| Investigational Site 054 | Boston | Massachusetts | Recruiting |
| Investigational Site 055 | Minneapolis | Minnesota | Recruiting |
| Investigational Site 012 | Rochester | Minnesota | Recruiting |
| Investigational Site 050 | Kansas City | Missouri | Recruiting |
| Investigational Site 046 | Kansas City | Missouri | Recruiting |
| Investigational Site 062 | St Louis | Missouri | Recruiting |
| Investigational Site 015 | New York | New York | Recruiting |
| Investigational Site 022 | New York | New York | Recruiting |
| Investigational Site 009 | Cincinnati | Ohio | Recruiting |
| Investigational Site 003 | Cleveland | Ohio | Recruiting |
| Investigational Site 005 | Austin | Texas | Recruiting |
| Investigational Site 066 | Houston | Texas | Recruiting |
| Investigational Site 013 | Houston | Texas | Recruiting |
| Investigational Site 042 | Burlington | Vermont | Recruiting |
| Investigational Site 006 | Charlottesville | Virginia | Recruiting |
| Investigational Site 023 | Norfolk | Virginia | Recruiting |
| Investigational Site 045 | Richmond | Virginia | Recruiting |
| Investigational Site 065 | Seattle | Washington | Recruiting |
| Investigational Site 027 | Ottawa | Ontario | Recruiting |
| Investigational Site 028 | Montpellier | France | Recruiting |
| Investigational Site 021 | Paris | France | Recruiting |
| Investigational Site 036 | Pessac | France | Recruiting |
| Investigational Site 019 | Poitiers | France | Recruiting |
| Investigational Site 037 | Toulouse | France | Recruiting |
| Investigational Site 038 | Toulouse | France | Recruiting |
| Investigational Site 052 | Dresden | Germany | Recruiting |
+ 26 more sites — see the full list on the official registry below.
More Kiniksa Pharmaceuticals International, plc trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07010159 on ClinicalTrials.gov ↗ ← All trials in France