NCT03627052撤回2 期
A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proportion of participants with a Clinical Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of UC at least 12 weeks before screening based on clinical, endoscopic, and histopathological evidence.
- •Have a 3-component Mayo score of 4 to 9, which includes a modified Mayo Endoscopy Score (mMES) of ≥ 2 as determined by a central reader, a rectal bleeding score of ≥ 1, and a stool frequency score of ≥
- •Must have failed or be intolerant to (discontinued the medication due to an adverse event as determined by the investigator) at least 1 of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine, biologic therapy (eg, infliximab, vedolizumab or adalimumab).
- •Participants currently receiving the following treatment(s) for UC are eligible, provided they have been receiving acceptable and stable dose(s): oral 5-ASA or oral corticosteroids.
- •No evidence of active or latent or inadequately treated tuberculosis infection.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Clinical signs of fulminant colitis or toxic megacolon.
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical or radiographic findings suggestive of Crohn's disease.
- •Disease limited to the distal 15 cm of the colon.
- •Receiving (or expected to receive) the following therapies within protocol-designated timeframes before the baseline visit or during the study: Natalizumab; anti-TNF therapy; Vedolizumab or any investigational anti-adhesion molecule therapy; Ustekinumab or any on or off label biologic therapy; interferon therapy; cyclosporine, mycophenolate, or tacrolimus; daily dose of oral corticosteroids ≥ 25 mg prednisone or equivalent; intravenous corticosteroids; rectally administered formulation of corticosteroids or 5-aminosalicylic acid; and AZA, 6-MP, or methotrexate.
- •Enema treatments within 2 weeks of the baseline visit, with the exception of enema bowel preparations for clinical assessments.
- •Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin at the screening visit.
- •Other immunocompromised states and history of opportunistic infections.
- •History of stomach or intestinal surgery, including bariatric surgery (Note: appendectomy and/or cholecystectomy, is allowed).
- •o surgery for UC or likely to require surgery for UC during the study.
- •If at risk for colorectal cancer, must have had a colonoscopy within protocol-defined timeframes.
- •History of recurrent, disseminated, or multiple dermatomal herpes zoster.
- •History of alcohol or drug abuse.
- •History of active malignancy within 5 years of screening, excluding superficial basal and squamous cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix.
- •Current or recent history (within 30 days before randomization) of a clinically meaningful viral, bacterial, fungal, parasitic, or mycobacterial infection.
- •Previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis (eg, Cellsorba) within 1 year of baseline.
- •History of unstable ischemic heart disease or uncontrolled hypertension.
- •Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for HCV antibody with detectable RNA at screening.
- •Participants taking potent systemic CYP3A4 inhibitors or inducers or fluconazole within 2 weeks or 5 half-lives (whichever is longer) of baseline.
- •Participants taking P-gp substrates with narrow therapeutic index, including digoxin within 2 weeks or 5 half-lives (whichever is longer) of baseline.
研究组 & 干预措施
Itacitinib
Experimental
干预措施: Itacitinib (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with a Clinical Response
时间窗: Week 8
To evaluate the efficacy of itacitinib inducing a Clinical Response.
次要结局
- Stool concentration of itacitinib -~30-hr collection(Week 4)
- Proportion of participants with Mucosal Healing(Week 8)
- Proportion of participants in Endoscopic Remission(Week 8)
- Change from baseline in 3-component Mayo score(Week 8)
- Cmax of itacitinib(Week 4)
- Proportion of participants with Endoscopic Response(Week 8)
- Change from baseline in Physician's Global Assessment score(Week 8)
- Change in Quality of Life score as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 8)
- Number of treatment-emergent adverse events(Up to approximately 60 weeks)
- Proportion of participants in Clinical Remission(Week 8)
- Ctau of itacitinib(Weeks 2 and 4)
研究者
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