A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)

Salix Pharmaceuticals, Inc.0 个研究点目标入组 336 人开始时间: 2021年6月2日最近更新: 2024年5月27日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Salix Pharmaceuticals, Inc.
入组人数: 336

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects will be eligible if they are male or female aged between 18 to 75 years at time of consent (inclusive) with stable vital signs and a diagnosis of active mild UC (modified Mayo Score of 3 or 4) or moderate UC (modified Mayo Score of 5 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
•Subjects must have an endoscopic subscore of =2 from and evidence of active UC extending =15 cm from the anal verge confirmed by a screening colonoscopy.
•If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (=20 mg prednisolone equivalent per day) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization.
•Subjects who complete the Double-Blind Period of the study who, in the opinion of the Investigator, would benefit from continued treatment may participate in the OLE Period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 320
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

排除标准

•Subjects will be excluded from the study if they have:
•Any of the following: a diagnosis of Crohn’s disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease, current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, proctitis (defined as a rectal inflammation within 15 cm from the anal verge), abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation; a history or evidence of any colonic resection or subtotal or total colectomy, ileostomy, colostomy, known fixed symptomatic stenosis of the intestine,
•unresected adenomatous colonic polyps, or colonic mucosal dysplasia.
•Clinically significant infections (e.g., pneumonia, pyelonephritis, or septicemia) within 4 weeks prior to randomization or previous clinically significant infections
•requiring hospitalization within 6 months prior to randomization, active or latent tuberculosis, infections of hepatitis B, hepatitis C, human immunodeficiency virus
•(HIV), or history of disseminated herpes zoster .
•Active SARS-CoV-2 infection or complications related to COVID-19.
•A history of, or currently active, primary or secondary immunodeficiency, presence of progressive multifocal leukoencephalopathy (PML), or presence of demyelinating diseases.
•A history or evidence of two or more failures with biologic treatment for UC.
•Currently taking any medication for treatment of UC other than oral or rectal 5-ASAs or oral corticosteroids (=20 mg prednisolone equivalent per day)
•Been taking enemas or suppositories (other than stable dose of 5-ASA) for treatment of UC within 2 weeks prior to the Screening Visit.
•Been taking an unstable dose of probiotics or antidiarrheals 2 weeks prior to the Screening Visit.
•Had recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, Class III/IV heart failure, Mobitz Type II 2nd degree or 3rd degree atrioventricular (AV) block, sick
•sinus syndrome, prolonged QT interval, Wolff Parkinson White or other conduction abnormalities, low heart rate, ongoing treatment with Class I or Class III anti-arrhythmic drugs, heart-rate-lowering calcium-channel blockers, ß-blockers or with any other drugs which can reduce the heart rate, have known high risk for QT/QTc prolongation, or have clinically significant abnormal findings in 12-lead ECG that the Investigator considers may jeopardize the subject’s health.
•Forced expiratory volume in one second (FEV1) or forced expiratory vital capacity (FVC) <70% of predicted values at screening. For sites where DLCO will be assessed, the value (mL/min/mmHg) is < 80% of the predicted normal value for age, height, and gender.
•Macular oedema as assessed by OCT.
•History of non-response or treatment failure with amiselimod or other sphingosine 1-phosphate (S1P) receptor modulators.
•Fecal microbiota transplantation (FMT) within 12 months prior to the Screening Visit.
•Any of the following laboratory abnormalities:
•o Hemoglobin (Hb) <9.0 g/dL.
•o White blood cell (WBC) count <3.50 × 10^9/L (<3,500/µL).
•o Absolute neutrophil count <1.50 × 10^9/L (<1,500/µL).
•o Absolute lymphocyte count <0.80 × 10^9/L (<800/µL).
•o Aspartate aminotransferase (AST) or alaninevaminotransferase (ALT) >2 × the upper limit of normal (ULN).
•o Bilirubin >1.5 x the ULN; subjects with Gilbert’s syndrome may be enrolled with total bilirubin up to 5.0 mg/dl.
•Positive stool tests for enteric pat

研究者

发起方

Salix Pharmaceuticals, Inc.

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