A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
研究概览
简要总结
A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.
详细描述
A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects with moderately-to-severely active Crohn's Disease. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age at screening
- •Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
- •Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
- •SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD]
- •Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
- •Additional inclusion criteria apply
排除标准
- •Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
- •Has a current bacterial, parasitic, fungal, or viral infection
- •Has clinically significant abnormalities in laboratory evaluations
- •Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
- •Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
- •Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
- •Additional exclusion criteria apply
研究组 & 干预措施
Active Treatment TD-1473 with Dose A
1 oral Dose A daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will continue to receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
干预措施: TD-1473 (Drug)
Active Treatment TD-1473 with Dose B
1 oral Dose B daily of TD-1473 for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will continue to receive TD-1473 at Dose B in the Active Treatment Arm for up to 48 additional weeks.
干预措施: TD-1473 (Drug)
Placebo
1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
干预措施: Placebo (Drug)
Placebo
1 oral dose daily of placebo for 12 weeks in subjects with moderately to-severely active CD.
Subjects who complete Induction will receive TD-1473 at Dose A in the Active Treatment Arm for up to 48 additional weeks.
干预措施: TD-1473 (Drug)
结局指标
主要结局
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score
时间窗: Baseline to Week 12
The CDAI score was generated using regression coefficients for eight different predictors of disease activity: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Benchmarks for disease activity as measured by the CDAI were: \<150, clinical remission; 150 to 219, mildly active disease; 220-450, moderately active disease; and \>450, very severe disease.
次要结局
- Number of Participants Who Demonstrated a Clinical Response as Measured by CDAI(Week 12)
- Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12(Baseline to Week 12)
- Number of Participants With Endoscopic Response at Week 12(Week 12)
- Number of Participants With Stool Frequency and Abdominal Pain (SFAP) Clinical Remission(Week 12)
- Number of Participants Who Demonstrated CDAI Clinical Remission(Week 12)