EUCTR2019-000176-41-IT进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment -
Otsuka Pharmaceutical Development and Commercialization, Inc0 个研究点目标入组 240 人开始时间: 2020年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •1) Diagnosis of Crohn's disease localized in the ileum and/or colon, with active mucosal inflammation and visible
- •lesion(s), documented by centrally read ileocolonoscopy and a Simple Endoscopic Score for Crohn’s Disease
- •(SES-CD) = 6 (= 4 for isolated ileal disease).
- •2) Subjects who do not have an optimal response (daily stool frequency > 3 and pain score > 1) to their current ongoing
- •treatment of biologics (eg, first anti-tumor necrosis factor-alpha [TNF-a] monoclonal antibody), immunosuppressants, low-dose steroids, or 5-aminosalicylic acid (5-ASA) formulations.
- •3) Subjects who are on stable Crohn’s disease medications for at least 4 weeks.
- •4) Subjects with a CDAI score between 180 and 450 points, inclusive.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) Low-dose steroids may be tapered down during the trial, based on inflammatory biomarkers and the investigator’s judgment.
- •2) Use of prednisone or prednisolone > 30 mg/day or budesonide > 9 mg/day within 4 weeks prior to screening; or intravenous steroids within 4 weeks prior to screening.
- •3) Subjects with known or suspected (family history, unexplained syncope) long QT syndrome or QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec for females or > 450 msec for males at baseline.
- •4) Subjects with known existing aortic aneurysm, or who are at risk for an aortic aneurysm, such as subjects with
- •peripheral atherosclerotic vascular diseases, uncontrolled hypertension, certain genetic conditions such as Marfan
- •syndrome and Ehlers-Danlos syndrome, and elderly subjects (over the age of 70).
- •5) Subjects with inadequate organ function, as follows: Serum creatinine > 1.5 x the upper limit of normal (ULN); Aspartate aminotransferase or alanine aminotransferase levels > 1.5 x ULN; Total bilirubin > 1.5 x ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
- •6) Known hypersensitivity to quinolones.
- •7) Subjects with a history of treatment failure with 2 or more biologics.
- •8) Subjects with risk factors for tendon rupture (ie, psoriasis, ankylosing spondylitis, competitive athletes, renal failure,
- •diabetes mellitus) or who have a history of tendon rupture and/or ongoing tendinopathy.
- •9) Subjects with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg.
- •10) Subjects taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol, amiodarone, ibutilide, dronedarone, or propafenone.
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