2024-514407-33-00招募中2 期
A Participant- and Investigator-blind, Randomised, Placebo controlled Phase II Study to Evaluate Safety, Tolerability, and Mucosal Repair with AZD7798 in Patients with Active Ileal Crohn’s Disease and an Ileostomy (CALLISTO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 14
- 主要终点
- Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.
研究概览
简要总结
To evaluate the safety and tolerability of repeated doses of AZD7798 in the induction period
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open Label Maintenance
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years of age inclusive, at the time of signing the ICF.
- •Diagnosis of Crohn’s disease established with clinical, imaging, endoscopic, and/or histopathologic evidence.
- •Ileostomy for at least 3 months.
- •Prior to screening endoscopy, clinical suspicion of active ileal inflammation based on at least one of the following: previous endoscopy, imaging (CT, MRI, IUS), or FCP above upper reference limit.
- •Active ileal Crohn’s disease as determined by active intestinal mucosal inflammation, as demonstrated on video recorded ileoscopy performed during the screening period and scored by a blinded central reader with agreement on the SES CD ≥ 4 of the ileal segment proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.
排除标准
- •Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation therapy.
- •Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum)
- •Short bowel syndrome.
- •Within 3 months prior to screening: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction
- •All intrabdominal, cutaneous and perianal/perirectal abscessesand fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications
- •Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
- •In patients with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: (a) Adenomatous colonic/rectal polyps that have not been removed (b) Intestinal dysplasia (c) Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
- •Reversal of ileostomy or formation of J-pouch planned prior to end of study period.
- •High-output stoma (eg, > 2000 mL/24 hours) associated with volume depletion and/or electrolyte disturbance to the extent that,in the opinion of the Investigator, it may put the patient at undue risk because of participation in the study, or impact their ability to participate in the study or interfere with the interpretation of study data.
结局指标
主要结局
Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.
Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.
次要结局
- Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs since week12 to week 52.
- a) Change from baseline in endoscopic score (SES CD using endoscopic assessment) at Week 12. b) Change from baseline in endoscopic score (MM SES-CD) at Week 12. c) Endoscopic response (≥ 50% decrease from baseline in SES-CD total score) at Week 12. d) Endoscopic remission (SES-CD total score < 4 and at least 2‑point reduction from baseline with no subscore > 1 in any individual variable) at Week 12.
- a) Serum AZD7798 concentration. b) Incidence and titre of ADA response
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (14)
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