A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients With Moderate to Severe Crohn's Disease

AstraZeneca157 个研究点分布在 8 个国家目标入组 120 人2024年8月28日

适应症Moderate to Severe Crohn's Disease

干预措施AZD7798 Placebo

概览

阶段: 2 期
干预措施: AZD7798
疾病 / 适应症: Moderate to Severe Crohn's Disease
发起方: AstraZeneca
入组人数: 120
试验地点: 157
主要终点: CDAI remission
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

注册库

clinicaltrials.gov

开始日期

2024年8月28日

结束日期

2027年5月14日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

AstraZeneca

责任方

Sponsor

入排标准

入选标准

•18 to 80 years of age.
•Diagnosis of Crohn's disease established with verifiable clinical, AND at least one of imaging, endoscopic and/or histopathologic evidence.
•Moderate to severe active Crohn's disease.
•Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.
•Capable of giving signed informed consent.
•A history of at least one of:
•Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
•Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day equivalent dosing without recurrent active disease) for the treatment of Crohn's disease.

排除标准

•Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
•Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon.
•Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.
•Evidence of extensive prior gastrointestinal surgical interventions.
•Within 3 months prior to screening endoscopy visit:
•History of toxic megacolon
•Diagnosis of peritonitis or need for treatment of peritonitis
•Bowel perforation or evidence of obstruction.
•All intrabdominal abscesses are excluded. Cutaneous and perianal/perirectal abscesses and fistulae are excluded unless adequately drained at least 4 weeks prior to screening endoscopy visit with no anticipation for surgery prior to end of study treatment.
•Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.

研究组 & 干预措施

AZD7798

干预措施: AZD7798

Placebo

干预措施: Placebo

结局指标

主要结局

CDAI remission

时间窗: Week 12

Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. It is based on: number of loose stools, abdominal pain, general well-being, extraintestinal complications, antidiarrheal agents used in the previous 7 days, abdominal mass felt on palpation, hematocrit and body weight