Phase 2/3 Study of KPL-387 in Recurrent Pericarditis (NCT07010159) | Clinical Trial Compass
RecruitingPhase 2/3
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
United States165 participantsStarted 2025-07-25
Plain-language summary
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Phase 2: Time to Treatment Response by Week 24
Timeframe: From Randomization up to Week 24
2
Phase 3: Time to Pericarditis Recurrence
Timeframe: From first administration of study drug in the RW Period
3
Long-Term Extension: Annualized rate of Pericarditis Recurrence