NCT05673902进行中（未招募）3 期
An Open-Label Clinical Study of the Safety and Efficacy of RPH-104 in Preventing Recurrences in Patients With Idiopathic Recurrent Pericarditis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Incidence rate for serious adverse events (SAEs)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of RPH-104 for long-term use in a population of patients with idiopathic recurrent pericarditis who completed the main study CL04018068.
The primary objective of the study is to evaluate the safety of RPH-104 80 mg once every 2 weeks in patients with idiopathic recurrent pericarditis who completed the main study.
详细描述
This long-term open-label study is an extension of the main double-blind, randomized, placebo-controlled study, CL04018068. This study will include the following periods:
- screening period - carried out on Day 0 (where Day 182, Week 26 from randomization in the main study CL04018068 will be considered as Day 0 of this study);
- re-screening period - up to 28 days (for patients who have completed the CL04018077 study);
- scheduled treatment period - 24-60 weeks (depends on the duration of treatment with RPH-104 during the main study CL04018068);
- safety follow-up period - 168 weeks. 60-week treatment re-initiation is possible in case of a disease recurrence reported during this period (with follow-up assessments 4 and 8 weeks after the last dosing of the investigational drug and telephone visits after 20, 32, 44, 56, 68, 80, 92 and 104 weeks after the administration of the final dose of the investigational drug, respectively).
It is planned that this study will include no more than 25 patients who completed the main study.
During the screening period, patients will be evaluated for eligibility for inclusion/non-inclusion in this study. Patients who do not meet these criteria will not receive treatment with the study drug.
Patients who meet the criteria for inclusion/non-inclusion in the study will enter the treatment period, where they will start open-label treatment with RPH-104 80 mg once every 2 weeks subcutaneously (SC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who fully completed per protocol a 24-week randomized withdrawal period (for the first 20 randomized patients), or the preparation therapy after the end of enrolment into the randomized withdrawal period in the main study CL
- •OR Patient who fully completed per protocol the study CL04018077 (after repeated screening).
- •Voluntarily signed and dated Patient Informed Consent Form for participation in this study.
- •The patient's ability and willingness, according to the investigator, to follow the schedule of visits, the study procedures and follow the protocol requirements, including the following:
- •Come to the study site every 2 weeks for the study drug administration by qualified site staff; or
- •Learn how to perform subcutaneous injections and do it on their own at home as per protocol of this study.
排除标准
- •Unwillingness or inability of the patient to perform the study procedures in accordance with the Protocol.
- •Any medically important event that was reported in a patient during his/her participation in the main study CL04018068, and, in the opinion of the Investigator, is a reason for not including this patient in this open-label study.
- •Pregnant and lactating women or women planning pregnancy during the study or within 2 months after the last dose of the study drug.
- •Women of childbearing potential who do NOT agree to use highly effective contraception methods throughout the study, starting from the moment of signing the informed consent form and for at least 8 weeks after the last dose of the study drug.
- •OR Men who are sexually active and do NOT agree to use highly effective contraception methods throughout the study, starting from the moment of signing the informed consent form and for at least 8 weeks after the last dose of the study drug.
- •Highly effective contraception methods include:
- •sterilization in women: surgical bilateral removal of the ovaries (with or without removal of the uterus) or ligation of the fallopian tubes at least 6 weeks before the start of the study therapy. In the case of removal of only the ovaries, the reproductive status of a woman should be confirmed by a subsequent assessment of hormone level;
- •sterilization in men, at least 6 months before the start of the study therapy with proper documentation of the absence of sperm in the ejaculate after vasectomy. For women participating in the study, a sexual partner after a vasectomy should be the only partner;
- •using a combination of any two of the following methods (a+b or a+c or b+c):
- •oral, injectable or implanted hormonal contraceptives; in the case of the use of oral contraceptives, women should continuously use the same drug for at least 3 months before the start of the study therapy;
- •an intrauterine device or contraceptive system;
- •barrier methods of contraception: condom or occlusive cap (diaphragm or cervical cap/contraceptive vaginal ring) with spermicidal foam/gel/film/cream/vaginal suppository.
- •The need to use a live (attenuated) vaccine during the study or within 3 months after the last dose of the study drug. Live attenuated vaccines include vaccines against the following viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhus vaccine). Immunocompetent family members of the patient should not be vaccinated with the oral polio vaccine during the patient's participation in the study.
- •Other medical conditions or laboratory abnormalities, which may increase the potential risk associated with participation in the study and treatment with the study drug, or may affect the interpretation of the results of the study, and which, in the opinion of the Investigator lead to patient ineligibility for this study.
- •Parallel participation in other clinical trials (except for the main study CL04018068) at the time of screening or the use of any unapproved (investigational) drugs (except for RPH-104) less than 4 weeks or 5 half-lives (whichever is greater) before screening.
- •For patients undergoing repeated screening, the following criteria are additionally applicable:
- •Hypersensitivity to the test drug (RPH-104), and/or its components /excipients and/or drugs of the same chemical class.
- •Previous use of drugs:
- •rilonacept - less than 6 weeks before the initial assessment (the day of the re-screening visit),
- •kanakinumab - less than 12 weeks before the initial assessment (the day of the re-screening visit),
- •anakinra - less than 5 days before the initial assessment (the day of the re-screening visit),
- •drugs of the TNF inhibitor class, IL-6 inhibitors, janus kinase inhibitors - less than 12 weeks before the initial assessment (the day of the re-screening visit),- - immunosuppressants (azathioprine, cyclosoprine, mycophenolate, mofetil, tacrolimus, sirolimus, mercaptopurine) - less than 24 weeks before the initial assessment (the day of the re-screening visit),
- •methotrexate - less than 2 weeks before the initial assessment (the day of the re-screening visit),
- •any other biological drugs in less than 5 periods half-life before the start of therapy.
- •Any conditions or signs in the patient that, according to the investigator's judgement, indicate a disorder (suppression) of the patient's immune response and/or significantly increase the risk of immunomodulatory therapy, including, but not limited to, the following:
- •active bacterial, fungal, viral or protozoal infection revealed at the beginning of the screening period;
- •opportunistic infections and/or Kaposi's sarcoma at the beginning of the screening period;
- •chronic bacterial, fungal or viral infection requiring systemic therapy at the beginning of the screening period;
- •HIV-infection, hepatitis B or C (patients with treated hepatitis C and negative polymerase chain reaction (PCR) tests after 3 and 6 months are regarded as cured from hepatitis C and can be included in this study);
- •A history of active tuberculosis or the presence of risk factors or signs indicating the presence of active or latent infection caused by M. Tuberculosis, including but not limited to the following:
- •living in specific conditions that increase the risk of contacts with tuberculosis-infected patients, such as prisons, gathering of homeless people etc. over the past year until the beginning of the main treatment period;
- •occupational exposure at a medical institution in the settings of unprotected contact with patients with a high risk of tuberculosis or patients with tuberculosis during the last year before the start of the screening period;
- •close contact, i.e. being in the same room (at home or in another confined environment) for an extended period of time (days or weeks rather than minutes or hours) with a person with active pulmonary tuberculosis within the past year prior to the beginning of the treatment period;
- •test results indicating active tuberculosis or latent infection caused by M. Tuberculosis: positive result of QuantiFERON-TB/T-SPOT test.TB during the screening period; findings of chest X-ray exam in two views confirming pulmonary tuberculosis during the screening period.
- •History of alcohol abuse or psychoactive substances abuse as assessed by the Investigator.
- •Severe renal impairment: creatinine clearance by Cockcroft-Gault formula <30 mL/min at the screening.
- •Presence of any of the following at the screening:
- •absolute neutrophil count <1.5 х 10^9/L,
- •white blood cells (WBC) count <3.5 х 10^9/L,
- •platelet count <100 х 10^9/L,
- •hemoglobin ≤ 80 g/L,
- •glycated hemoglobin (HbA1c) ≥ 8% (to be evaluated only in patients with diabetes mellitus),
- •alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 3.0 х upper limit of normal (ULN),
- •total bilirubin >1.5 х ULN (except for cases of documented Gilbert's syndrome).
研究组 & 干预措施
RPH-104 80 mg
Experimental
RPH-104 80 mg SC once every 2 weeks for 24-60 weeks.
(If the patient develops a pericarditis recurrence during the safety follow-up period, at the discretion of the investigator treatment with the study drug might be re-initiated according to the following regimen: a single dose of 160 mg SC (first injection) followed by a dose of 80 mg SC 7 days and 14 days after the first injection and at doses of 80 mg SC every two weeks thereafter.)
干预措施: RPH-104 (Biological)
结局指标
主要结局
Incidence rate for serious adverse events (SAEs)
时间窗: Up to week 228
Incidence rate, expressed as the number of events per 100 patient-years of follow-up, for SAEs
Incidence rate for adverse events of special Interest (AESI)
时间窗: Up to week 228
Incidence rate, expressed as the number of events per 100 patient-years of follow-up, for AESI
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term
时间窗: Up to week 228
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term
时间窗: Up to week 228
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI), by System Organ Class and Preferred Term
时间窗: Up to week 228
次要结局
- Change from the baseline in the patient quality of life as assessed using the SF-36 questionnaire period during a 24-week treatment period and the entire study treatment period(baseline, weeks 24, 60)
- Proportion of patients with pericarditis recurrence during 24 weeks of therapy in the study and during the entire period of the study treatment(weeks 24, 60)
- Proportion of patients with pericarditis recurrence during 24 weeks of the follow-up period and during the entire follow-up period of the study(weeks 24, 228)
- Change from the baseline in the physician's overall disease score on the numeric rating scale period during a 24-week treatment period and the entire study treatment period(baseline, weeks 24, 60)
- Change from the baseline in C-reactive protein (CRP) levels during 24 weeks of therapy in the study and during the entire period of the study treatment(baseline, weeks 24, 60)
- Change from the baseline in the size of pericardial effusion according to Echo-CG during 24 weeks of therapy in the study and during the entire period of the study treatment(baseline, weeks 24, 60)
- Change from the baseline in the chest pain intensity as assessed by patients on the numeric rating scale during a 24-week treatment period and the entire study treatment period(baseline, weeks 24, 60)
- Change from the baseline in patients' overall health scores on the numeric rating scale period during a 24-week treatment period and the entire study treatment period.(baseline, weeks 24, 60)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean FeverFamilial Mediterranean FeverFMFNCT05190991R-Pharm International, LLC60
暂停
2 期
Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent PericarditisRecurrent PericarditisNCT05107934R-Pharm Overseas, Inc.80
已完成
1 期
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy SubjectsHealthyNCT02667639R-Pharm35
已完成
2 期
Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent PericarditisPericarditisNCT04692766R-Pharm International, LLC20
撤回
2 期
Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler SyndromeSchnitzler SyndromeUrticarial Vasculitis With Monoclonal Immunoglobulin M Component, Schnitzler (Disorder)NCT04213274R-Pharm Overseas, Inc.14