A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants with Recurrent Pericarditis
Date de révision : 24/04/2026
6 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 23/04/2026
Critères :
Critères d'inclusion :
- 1. Is capable of understanding the informed consent form (ICF), has provided signed informed consent, and agrees to comply with protocol requirements.
- 10. If female, must be either postmenopausal (defined as no menses for 12 consecutive months without other medical cause), permanently surgically sterile (i.e., removal of ovaries, fallopian tubes, and/or uterus), or, for women of childbearing potential*, must: Be nonpregnant, nonlactating, and agree to remain abstinent or use a highly effective method of contraception with a failure rate of < 1% per year from the Screening Visit until the end of study participations and at least 8 weeks after last study drug dose. Examples of contraception methods with a failure rate of < 1% per year include: o Hormonal contraceptives associated with inhibition of ovulation (stable dose for at least 4 weeks prior to first dose of study drug); hormonal contraceptive methods must be supplemented by a barrier method o Hormone-releasing or copper intrauterine device o Other intrauterine system o Bilateral tubal occlusion o Vasectomized male partner o Abstinence from heterosexual intercourse; The reliability of sexual abstinence should be evaluated based on duration of the study and usual lifestyle of the participant. Intermittent abstinence (such as calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not considered acceptable contraceptive methods. *The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- 11. Sexually active male participants must have documented vasectomy or must agree to use a method of contraception with a failure rate of < 1% per year (as defined in inclusion criterion #10 above) with partners of childbearing potential through the end of study participation and at least 8 weeks after last study drug dose.
- 12. Male participants must agree to refrain from donating sperm through the end of study participation and at least 8 weeks after last study drug dose. Female participants must agree to refrain from donating eggs through the end of study participation and at least 8 weeks after last study drug dose.
- 13. Agrees to refrain from lifestyle changes that may affect pericarditis symptoms (e.g., significant changes to exercise pattern) except as recommended by the Investigator from the time the ICF is signed through the end of Part A or Part B.
- 2. Is ≥ 18 and < 81 years of age.
- 3. Has a body weight of at least 40 kg at Screening.
- 4. Has a history, or current clinical diagnosis, of pericarditis that, in the opinion of the Investigator, is consistent with the 2015 ESC Guidelines for the Diagnosis and Management of Pericardial Diseases definition (Adler 2015), based on documented available data, fulfilling at least 2 of the following 4 criteria: a. Pericarditic chest pain b. Pericardial rub c. New widespread ST segment elevation or PR segment depression according to ECG findings d. Pericardial effusion (new or worsening)
- 5. Presents at Screening with signs and symptoms of acute pericarditis (Qualifying Pericarditis Episode) despite treatment with standard therapies that represents either: a. At least the second recurrence (i.e., at least the third pericarditis episode), with the initial acute pericarditis episode having been followed by a symptom-free interval; OR b. Persistent pericarditis signs and symptoms despite initial improvement without a symptom-free interval.
- 6. Qualifying Pericarditis Episode is confirmed by presence of both: a. At least 1 day with pericarditis pain ≥ 4 on the 11-point NRS; AND b. At least 1 CRP level ≥ 1.0 mg/dL (either local or central laboratory result) drawn within 7 days before or after the qualifying NRS. *A Qualifying Pericarditis Episode should have occurred within the 7 days prior to Part A Treatment Baseline Visit or Part B RI Baseline Visit (first study drug administration). Pericarditis pain (NRS ≥ 4) and CRP ≥ 1 mg/dL are not required to be present on the same day.
- 7. Pericarditis medications at Baseline: Part A: NSAIDs and/or colchicine (in any combination), if used, have been maintained at stable dose levels (not increased) for at least 72 hours prior to Baseline (first study drug administration), and changes in medications made within this time period (e.g., 1-time use of NSAIDs) are not anticipated to significantly alter assessments of Baseline disease activity in the opinion of the Investigator. Concomitant glucocorticoid use is not permitted in Part A, and prior use must have been discontinued at least 72 hours prior to first study drug administration. Part B: NSAIDs and/or colchicine and/or glucocorticoids (in any combination), if used, have been at stable dose levels (not increased) for at least 72 hours prior to RI Baseline (first study drug administration), and changes in medications made within this time period (e.g., 1-time use of NSAIDs) are not anticipated to significantly alter assessments of Baseline disease activity in the opinion of the Investigator.
- 8. Participant is willing to and, in the opinion of the Investigator, is expected to be able to discontinue all permitted prior/concomitant pericarditis medications after initiation of study drug within the protocol-specified windows.
- 9. Routine adult vaccinations should be up to date or offered at least 2 weeks prior to randomization according to regional and national guidelines based on medical history or presence of risk factors, in the opinion of the Investigator.
Critères d'exclusion :
- 1. Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies, including: a. Tuberculosis (TB) b. Neoplastic, purulent, or radiation etiologies c. Post-thoracic blunt trauma (e.g., motor vehicle accident) d. Systemic autoimmune disease e. Concurrent extensive myocardial inflammation and/or injury as evidenced by • New regional wall motion abnormalities or new global left ventricular systolic dysfunction • Cardiac Troponin level > 5 × ULN (as per local laboratory testing)
- 10. 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.
- 11. Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring more than one dose of parenteral (IV or IM) antibiotics within 8 weeks prior to first study drug administration, or has been treated with oral (or single dose parenteral) antibiotics for a documented infection within 2 weeks prior to first study drug administration.
- 12. Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- 13. Most recent screening laboratory test results indicating any of the following criteria: a. Hemoglobin level < 10.0 g/dL b. WBC count < 3.0 × 103/μL c. Neutrophil count < 1.5 × 103/μL d. Platelet count < 100 × 103/μL e. Total bilirubin level > 1.5 × the upper limit of normal (ULN) unless the test results are consistent with those for Gilbert’s syndrome f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values > 2× ULN
- 14. Has a known hypersensitivity to KPL-387 or to any of its excipients.
- 15. Has any medical condition that, in the opinion of the Investigator, could interfere with, protocol compliance, evaluation of the study drug effects, interpretation of participant safety events, or confound the results of the study. This includes, but is not limited to, significant concomitant cardiac, renal, neurological, endocrinological, metabolic, pulmonary, or gastrointestinal disease, and psychiatric or substance use disorders.
- 16. Is not likely to be compliant with the study protocol, in the opinion of the Investigator.
- 2. Concurrent or prior treatments within the washout periods prior to first dose of study drug, defined in the table in Protocol.
- 3. Positive (or 2 indeterminate) QuantiFERON® or other interferon gamma release assay (IGRA) test results unless confirmation of prior completion of appropriate treatment for latent TB and no evidence of active TB. a. IGRA test will be performed during Screening unless participant has a previously documented negative IGRA result within 8 weeks prior to Screening or documented prior positive IGRA at any time. b. An indeterminate IGRA test should be repeated. c. A positive or two successive indeterminate IGRA results should be considered a positive diagnostic TB test. d. An indeterminate followed by a negative IGRA test should be considered a negative diagnostic TB test.
- 4. Has a history of immunodeficiency.
- 5. Has a positive human immunodeficiency virus (HIV) test. HIV test will be performed during Screening unless participant has a previously documented negative HIV result within 8 weeks prior to Screening.
- 6. Has chest x-ray at Screening (or history of results within 12 weeks before first study drug administration) with evidence of malignancy, abnormality consistent with prior or active TB infection, active infection, or any other medical condition that could adversely affect study participation or interfere with study evaluations, in the opinion of the Investigator.
- 7. Has positive or intermediate results for hepatitis C virus (HCV) infection or chronic active hepatitis B infection at Screening as defined below: a. Hepatitis C antibody positive unless confirmed to have negative PCR test of HCV RNA b. Hepatitis B surface antigen positive c. Hepatitis B anti-core antibody positive and anti-surface antibody negative d. Consultation with a liver disease expert is recommended prior to enrollment of any participants with either hepatitis C antibody positive (and negative PCR) OR hepatitis B anti-core antibody positive and anti-surface antibody positive.
- 8. Has an estimated glomerular filtration rate (eGFR) < 30 mL/min, by laboratory standard practice (e.g., Modification of Diet in Renal Disease [MDRD] formula).
- 9. 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).
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Centre Hospitalier Universitaire De Montpellier
34000 Montpellier France
Centre Hospitalier Universitaire De Toulouse
31059 Toulouse Cedex 9 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".