2025-523234-66-00招募中2 期
A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies
Kiniksa Pharmaceuticals GmbH25 个研究点 分布在 6 个国家目标入组 22 人开始时间: 2026年1月2日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 25
- 主要终点
- Primary Efficacy Endpoint – Posology Period: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence.
研究概览
简要总结
Primary Objective – Posology Period: To characterize the efficacy of the dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis (RP) on standard therapies.
Primary Objective – LTE Period: To evaluate the long-term efficacy of KPL-387
研究设计
- 分配方式
- Na
- 主要目的
- Open label Long-Term Extension (LTE)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Each participant must meet all of the following criteria to be enrolled in this study: Is capable of understanding the written ICF, has provided signed written informed consent, and agrees to comply with protocol requirements.
- •If female, must be either postmenopausal (defined as no menses for 12 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 after the end of study participation and at least 8 weeks after the last KPL-387 dose. Examples of contraception methods with a failure rate of < 1% per year include: a. Hormonal contraceptives associated with inhibition of ovulation (stable dose for at least 4 weeks prior to first dose of KPL-387); hormonal contraceptive methods must be supplemented by a barrier method b. Hormone-releasing or copper intrauterine device c. Bilateral tubal occlusion d. Vasectomized male partner e. 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 post-ovulation) and withdrawal are not considered acceptable contraceptive methods *The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- •Sexually active male participants must have documented vasectomy or must agree to use a condom or method of contraception with a failure rate of <1% per year, as defined above with their partners of childbearing potential through the end of study participation and at least 8 weeks after last KPL-387 dose.
- •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 KPL-387 dose.
- •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 the Posology Period.
- •Is > 18 years of age and < 81 years of age at Screening.
- •Has a body weight of at least 40 kg at Screening.
- •Has a history of pericarditis that in the opinion of the Investigator was consistent with the 2015 ESC Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler 2015) based on the documented available data, fulfilling at least 2 of the following 4 criteria: • Pericarditic chest pain • Pericardial rub • New widespread ST segment elevation or PR segment depression according to ECG findings • Pericardial effusion (new or worsening). Note: Additional supporting findings include: Elevation of markers of inflammation (i.e. C-reactive protein, erythrocyte sedimentation rate, and white blood cell count); Evidence of pericardial inflammation by an imaging technique (CT, CMR).
- •Currently has RP which is well-controlled, i.e., including having CRP < 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline.
- •Has a documented history of CRP elevation (> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence.
- •Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen as listed in the protocol section 4.1, page 43
- •Participant is willing to and, in the opinion of the Investigator, is expected to be able to discontinue all permitted/prior pericarditis medications after initiation of study drug within protocol defined windows.
- •Routine adult vaccinations should be up to date or offered at least 2 weeks prior to first study drug administration according to regional and national guidelines based on medical history or presence of risk factors, in the opinion of the Investigator.
排除标准
- •Participants meeting any of the following criteria will be excluded from this study: 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 diseases e. Concurrent extensive myocardial inflammation and/or injury as evidenced by: • New regional wall motion abnormalities or new global left ventricular systolic dysfunction • [CCI]
- •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 polymerase chain reaction (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 hepatitis B anti-core antibody positive and anti-surface antibody positive results.
- •Has an estimated glomerular filtration rate < 30 mL/min, by laboratory standard practice (e.g., MDRD formula).
- •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).
- •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.
- •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 intramuscular) 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).
- •Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- •Has 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 ULN unless the test results are consistent with those for Gilbert’s syndrome f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 × ULN
- •Has a known hypersensitivity to KPL-387 or to any of its excipients.
- •Has any medical condition that, in the opinion of the Investigator, could interfere with protocol compliance, evaluation of the study drug effects, or interpretation of participant safety events or confound the study results. This includes but is not limited to significant concomitant cardiac, renal, neurological, endocrinological, metabolic, pulmonary, or gastrointestinal disease, and psychiatric or substance use disorders.
- •Is not likely to be compliant with the study protocol, in the opinion of the Investigator.
- •Has had a pericarditis recurrence in the last 3 months prior to Baseline.
- •Has clinical worsening of pericarditis signs/symptoms (e.g., more than mild pericardial pain) or clinical suspicion of impending pericarditis recurrence during Screening.
- •Has had prior lack of efficacy while receiving anakinra (100 mg SC once-daily dosing regimen) or rilonacept (160 mg SC once-weekly dosing regimen), or discontinuation of therapy due to safety concerns (other than local injection site reactions [ISRs])
- •Is receiving/has received concurrent or prior treatments within the washout periods prior to first dose of study drug, defined in the table on page 43 section 4.2
- •Has a 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.
- •Has a history of immunodeficiency.
- •Has a positive human immunodeficiency virus (HIV) test result. HIV test will be performed during Screening unless participant has a previously documented negative HIV result within 8 weeks prior to Screening.
- •Has chest x-ray at Screening (or history of results within 12 weeks before receiving 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.
研究组 & 干预措施
KPL-387
Test
干预措施: KPL-387 (Drug)
结局指标
主要结局
Primary Efficacy Endpoint – Posology Period: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence.
Primary Efficacy Endpoint – Posology Period: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence.
Primary Efficacy Endpoint – LTE Period: Annualized rate of Pericarditis Recurrence through the end of the LTE Period. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE Period.
Primary Efficacy Endpoint – LTE Period: Annualized rate of Pericarditis Recurrence through the end of the LTE Period. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE Period.
Primary Efficacy Endpoint – Posology Study: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence.
Primary Efficacy Endpoint – Posology Study: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence.
Primary Efficacy Endpoint – LTE: Annualized rate of Pericarditis Recurrence through the end of the LTE. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE.
Primary Efficacy Endpoint – LTE: Annualized rate of Pericarditis Recurrence through the end of the LTE. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE.
次要结局
未报告次要终点
研究者
Medical Information Team
Scientific
Kiniksa Pharmaceuticals GmbH
研究点 (25)
Loading locations...
相似试验
招募中
2 期
Transition to KPL-387 Monotherapy Dosing & Administration StudyRecurrent PericarditisPericarditisNCT07288216Kiniksa Pharmaceuticals International, plc80
尚未招募
1 期
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard TherapyNon-small Cell Lung CancerNCT07423117IntoCell, Inc102
招募中
3 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) plus BSC versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk MDS2022-500479-29-00Celgene Corp.166
招募中
2 期
A phase 1/2 study of SLN124 in patients with Polycythemia VeraPolycythemia Vera2023-503544-13-00Silence Therapeutics PLC68
招募中
2 期
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, as Monotherapy or in Combination with a Checkpoint Inhibitor in Patients with Recurrent and/or Refractory Solid Tumors2022-503133-54-00Immatics Biotechnologies GmbH130