EUCTR2021-002308-11-ES进行中（未招募）1 期
A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to severely active ulcerative colitis with an inadequate response to conventional therapy.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age = 2 and < 17 years of age
- •-Have had UC diagnosed prior to the Screening Visit. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report
- •-Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
- •-Has moderately to severely active UC, defined as a 4-component Mayo Score = 6 and = 12 at the time of screening, including the following: Mayo Endoscopy Subscore = 2, Rectal Bleeding Score = 1, and Stool Frequency Score = 1.
- •-Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
- •-Subjects may concurrently receive treatment with oral 5-ASAs, or with prednisone or equivalent (= 0.5 mg/kg/ day up to 20 mg/day).
- •-Must have documentation of vaccinations per standard immunization schedule including complete Varicella zoster virus (VZV) vaccination at least 30 days prior to randomization, or documentation of positive Varicella zoster virus (VZV) Immunoglobulin G (IgG) antibody.
- •-Females of childbearing potential (FCBP)[1] must agree to practice a highly effective method of contraception[2] throughout the study until completion of the 90-day Safety Follow-up Visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
- •-Diagnosis of Crohn’s disease, indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease or microscopic colitis, radiation colitis or ischemic colitis.
- •-Has documentation of positive test for toxin producing Clostridium difficile (C. difficile), or polymerase chain reaction (PCR) examination of the stool. If positive, subjects may be rescreened after appropriate treatment and retested no earlier than 7 days after completion of treatment.
- •-History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks of Screening endoscopy or anti-motility medications (such as diphenoxylate/atropine) during Screening.
- •-Apheresis within 2 weeks of randomization.
- •-Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (ß-hCG) measured during Screening.
- •-History or presence of the following clinically relevant cardiovascular conditions:
- •Structural cardiac disease
- •Cardiac events or diseases that predispose to cardiac complications
- •Prolonged QT interval corrected for heart rate or is at additional risk for QT interval prolongation During either Screening or Baseline Day 1 pre-dose assessmsnt, resting HR < 55 bpm in subjects 12-17 years old, resting HR < 65 bpm in subjects 6-11 years old, or resting HR < 75 bpm in subjects 2-5 years old.
- •Severe untreated sleep apnea
- •-History of diabetes mellitus (DM)
- •-History of uveitis or history or evidence of retinal disease.
- •-Subject has any known active bacterial, viral, fungal, mycobacterial infection or any major episode infection that required hospitalization or treatment with IV antibiotics within 30 days of Screening or oral antibiotics within 14 days of screening.
- •-Recurrent or chronic infection recurrent urinary tract infections are allowed.
- •-Any history of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved) or colonic dysplasia that has not been completely removed.
- •-History of or currently active primary or secondary immunodeficiency, or subjects with known genetic disorders as a cause for colitis
- •Exclusions related to laboratory abnormalities (at time of screening visit):
- •-ECG showing any clinically significant abnormality.
- •-Serum creatinine > 1.4 mg/dL for females, or > 1.6 mg/dL for males.
- •-Liver function impairment; or, persisting elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x upper limit of normal (ULN); or, direct bilirubin > 1.5x ULN.
- •-Platelet count < 100,000/µL.
- •-Hemoglobin < 8.0 g/dL..
- •-Neutrophil count < 1500/µL.
- •-Absolute white blood count < 3500/µL.
- •-ALC < 800/µL.
- •-Stool positive for pathogens.
- •-In subjects with recent pulmonary function test measurements: (FEV1) or (FVC) at < 70% of predicted values.
- •Exclusions related to medications
- •-Hypersensitivity to active ingredients or excipients of ozanimod.
- •-Treated with a biologic agent or 5 elimination half-lives (whichever is shorter) prior to the first dose of IP.
- •-Treated with an investigational agent
- •-Received a live or live attenuated vaccine
- •-Received any previous treatment
研究者
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