EUCTR2016-000390-20-CZ进行中（未招募）1 期
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
TOPIVERT Pharma Limited0 个研究点目标入组 80 人开始时间: 2016年7月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Male or female subjects, 18 to 75 years of age, with a documented
- •diagnosis of UC of at least 3 months duration prior to Screening, based
- •on medical history, endoscopy, and (if available) histological findings.
- •Eligible subjects will have a Partial Mayo Clinic Score of 4 to 8,
- •consisting of all of the following:
- •Endoscopy subscore =2 (as per central read)
- •Rectal bleeding subscore =1
- •Stool frequency subscore =1
- •Disease activity extending at least 15 cm proximally from the anal verge
- •In addition, eligible subjects:
- •Will be receiving a stable dose regimen of oral 5-aminosalicylic acid (5-
- •ASA; =4.8 g/day) for at least 2 weeks prior to the Screening endoscopy,
- •and be willing to continue the regimen for the duration of the study (required of all subjects in the Czech Republic); or
- •If not currently receiving oral 5-ASA, must have received it previously
- •and experienced a therapeutic failure or intolerance, or have a
- •contraindication to aminosalicylates (applies to subjects in all
- •participating countries except the Czech Republic).
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Receiving any rectally administered medication (i.e., any such
- •medication, including topical corticosteroids and topical 5-ASA
- •preparations must have been withdrawn at least 2 weeks prior to
- •Screening endoscopy).
- •2. Use of biologic agents (including anti-tumour necrosis factor [TNF]
- •agents and vedolizumab) within 3 months of Screening endoscopy, or 5
- •half-lives, whichever is longer.
- •3. Use of IV corticosteroids within 4 weeks prior to Screening endoscopy.
- •4. Use of oral corticosteroids at a dose >30 mg/day (or budesonide >9
- •5. In general, patients who have started receiving immune suppressants
- •within 3 months of the Screening endoscopy should not be included.
- •Patients on stable doses of the following medications for 3 months
- •before the Screening endoscopy will be allowed: azathioprine, 6-
- •mercaptopurine, or methotrexate.
- •6. Participated in another study of an investigational medication (or a
- •medical device) within the last 3 months or 5 half-lives of the
- •investigational medication, whichever is longer, or is currently
- •participating in another study of an investigational medication (or a
- •medical device).
- •7. Known hypersensitivity to any components of the IMP.
- •8. At Randomisation, a Partial Mayo Clinic Score of 9 (from the sum of
- •the endoscopy subscore, rectal bleeding subscore, and stool frequency
- •9. Known or suspected pancolitis (unless on oral 5-ASA, steroids or
- •permitted immunomodulators as described in the Section 5.8).
- •10. Known or suspected Crohn's disease, indeterminate colitis,
- •microscopic colitis, ischaemic colitis, or radiation-induced colitis, based
- •on medical history, endoscopy, and/or histological findings.
- •11. Extensive (>50%) colonic resection or colectomy, or prior history of
- •toxic megacolon within 3 months of Screening.
- •12. History or presence of colonic mucosal dysplasia. Patients with
- •dysplasia within a completely resected adenomatous polyp may be
- •13. Positive history of human immunodeficiency virus, hepatitis B
- •surface antigen, or hepatitis C.
- •14. Known history of and/or recent alcohol abuse that, in the opinion of
- •the Investigator, could influence safety of patient participation in the
- •15. Any acute or chronic illness (other than UC) affecting the colon
- •and/or rectum and/or anus
- •16. Any acute or chronic comorbidity, including cardiovascular, renal,
- •hepatic, endocrine, pulmonary, or gastrointestinal,
- •17. Current evidence of or treatment for a malignancy within the past 3
- •years, other than localised basal-cell or squamous-cell skin cancer,
- •cervical dysplasia, or carcinoma in situ that has been definitively treated
- •with standard of care.
- •18. Patient has active serious infection (e.g., sepsis, pneumonia,
- •abscess) or has had a serious infection (resulting in hospitalisation or
- •requiring parenteral antibiotic treatment) within 6 weeks prior to IMP
- •administration.
- •19. Patients testing positive for Clostridium difficile toxin or confirmed
- •with bacterial or parasitical GI infections at Screening. Patients who test
- •positive for C difficile antigen or who test positive for Blastocystis
- 另有 8 项未显示
研究者
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