NCT06450197进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 120
- 试验地点
- 152
- 主要终点
- CDAI remission
研究概览
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.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Symptomatic strictures or bowel stenoses, or strictures preventing passage of endoscope throughout the colon (including at screening endoscopy).
- •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.
- •Evidence of an increased risk of colorectal cancer.
- •Symptomatic oral Crohn's disease within one year.
- •Any of the following treatments within the specified time period prior to screening endoscopy visit
- •An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
- •Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
- •Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
- •Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
- •Treatment with apheresis within 4 weeks prior to screening endoscopy visit
- •Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
- •Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
- •Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
- •Any previous exposure to AZD
- •Any initiation or changes in dosing of the following medications prior to screening endoscopy visit as outlined: (a) 5-aminosalicylates within 2 weeks (b) Oral corticosteroids within 2 weeks or stable doses of steroids exceeding the following dose equivalents: (i) Systemic steroids > 20 mg/day or prednisolone equivalent (ii) Steroids with limited systemic effects (eg, budesonide and beclomethasone), exceeding maximum budesonide dose equivalent (9 mg/day) (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks.
- •Chronic use of nonsteroidal anti-inflammatory drugs.
- •Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit.
- •Evidence of chronic HBV or HCV.
- •History of TB (active or latent) unless an appropriate course of treatment has been completed.
- •Positive diagnostic TB test at screening.
- •History of serious opportunistic infection within 12 months prior to screening endoscopy visit.
- •CMV colitis within previous 12 months prior to screening endoscopy visit.
- •Positive C. difficile toxin stool test at screening.
- •Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.
- •Any identified immunodeficiency.
- •Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results.
- •Reproduction:
- •Pregnant and breastfeeding patients, or those planning to breastfeed during the study
- •FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.
- •Prolonged QTcF interval.
- •Clinically significant cardiovascular conditions.
- •Current malignancy or history of malignancy.
- •Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease.
- •Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.
- •Unstable lifestyle factors.
- •Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Investigator concerns regarding patient's willingness and ability to attend all study visits, comply with the study procedures, read in order to complete questionnaires, or to complete the study period
研究组 & 干预措施
AZD7798
Experimental
AZD7798
干预措施: AZD7798 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
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
次要结局
- Symptomatic remission(Week 12)
- Endoscopic response(Week 12)
- Endoscopic remission(Week 12)
- Endoscopic score change from baseline(Week 12)
- CDAI response(Week 12)
- CDAI score change from baseline(Week 12)
- Serum AZD7798 concentration(Up to 85 days)
- Incidence of anti-drug antibody response(Up to 36 weeks)
- Titre of anti-drug antibody response(Up to 36 weeks)
研究者
研究点 (152)
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