EUCTR2020-000048-73-DE进行中（未招募）1 期
A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The study will enroll male and female adult subjects with chronic antibiotic-resistant pouchitis. Inclusion criteria (subjects must meet the following criteria to be randomized into the study):
- •1. Male and female subjects aged 18 to 75 yrs, inclusive.
- •2. IPAA for UC completed at least 1 yr prior to screening.
- •3. Active signs and symptoms of pouchitis, as follows:
- •a. Modified Pouchitis Disease Activity Index (mPDAI) score = 5, and,
- •b. Increased stool frequency, defined as 3 more stools per day above normal” (after IPAA) and an absolute total of = 6 stools per day.
- •Increased stool frequency is calculated as the difference between Normal and Screening stool frequency.
- •Normal is the stool frequency achieved post-IPAA when the subject's bowel function was most settled. This typically occurs approximately 1 year after IPAA and should be supported by documentation in the subject's medical records. If stool frequency never normalized after IPAA, consult with the Medical Monitor to determine if pre-IPAA stool frequency is appropriate.
- •To be eligible for the study, subjects must experience 6 or more stools per day, and this value must be 3 or more stools per day greater than the Normal value, as defined above.
- •4. Chronic or recurrent pouchitis, defined by:
- •a. = 2 episodes within 1 year prior to or including the screening period treated with antibiotic or other prescription therapy, or,
- •b. Maintenance antibiotic therapy taken continuously for =4 weeks immediately prior to the screening endoscopy.
- •5. Antibiotic-resistant pouchitis, defined as disease remaining active despite at least 2 weeks of antibiotic therapy.
- •6. Histologic inflammation in the pouch, defined by a Geboes score of 3.1 or greater.
- •7. Unlikley to conceive.
- •8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit prior to the first dose of study drug.
- •9. Able to participate fully in all aspects of this clinical trial.
- •10. Written informed consent must be obtained and fully documented.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Exclusion criteria (subjects who meet any of the following criteria are not eligible for participation in the study):
- •1. Known Crohn’s disease (CD) or suspected CD of the pouch, defined as complex perianal/pouch fistula and/or extensive length of pre-pouch ileitis with deep ulceration.
- •2. Diagnosed or suspected irritable pouch syndrome (IPS).
- •3. Isolated or predominant cuffitis.
- •4. Mechanical complications of the pouch such as stricture or fistula(e) that preclude evaluation of the pouch and terminal ileum.
- •5. Fecal incontinence due to anal sphincter dysfunction.
- •6. Pelvic sepsis within 12 months prior to screening.
- •7. Planned surgery for UC, or any other elective surgery within the time frame of the study.
- •8. Diverting stoma.
- •9. Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile; known infection with hepatitis B or C virus; known infection with human immunodeficiency virus; infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; history of more than 1 episode of herpes zoster or any episode of disseminated zoster.
- •10. A positive diagnostic tuberculosis (TB) test at screening (defined as a positive QuantiFERON test).
- •11. Prior biologic use restrictions and exclusions:
- •a. No more than 60% of enrolled subjects in Phase 2 and no more than 25% of enrolled subjects in Phase 3 may have prior failure of any biologics for pouchitis.
- •b. Subjects who have used prior biologic therapies must have discontinued within 12 weeks or 5 half-lives of screening (or within 4 weeks if drug levels are undetectable).
- •12. Use of any of the following prohibited therapies, except under the stated conditions (if applicable):
- •a. Opioids within 4 weeks prior to screening.
- •b. Chronic use (>4 weeks of continuous use prior to screening) of nonsteroidal anti-inflammatory drugs, except for chronic use of low-dose 81 mg aspirin.
- •c. Oral 5-aminosalicylate (5-ASA), unless the dose is = 4.8 g/day and has been stable for at least 4 weeks prior to screening.
- •d. Oral budesonide within 6 weeks of screening.
- •e. Other oral corticosteroids at daily doses > 20 mg prednisone or equivalent, or who started oral corticosteroids within 6 weeks prior to screening; stable doses = 20 mg prednisone or equivalent for at least 4 weeks prior to screening are permitted.
- •f. Any rectal compounds.
- •g. Immunosuppresant therapy (azathioprine, 6-mercaptopurine, methotrexate, cyclosporin) within 8 weeks prior to screening.
- •h. Fecal transplant within 12 weeks prior to screening.
- •i. Live virus vaccination within 1 month prior to screening.
- •j. Any investigational therapy within 4 weeks prior to screening.
- •13. Diagnosed with any immune deficiency.
- •14. History of malignancy, except for basal cell carcinoma, nonmetastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.
- •15. Clinically meaningful laboratory abnormalities at screening that would affect subject safety, as judged by the investigator from local testing.
- •16. A concurrent, clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitoruinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might co
研究者
相似试验
进行中（未招募）
1 期
A study of AMT-101 in patients with Pouchitis.MedDRA version: 20.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disordersPouchitisEUCTR2020-000048-73-HUApplied Molecular Transport Inc.144
进行中（未招募）
1 期
A study of AMT-101 in patients with Pouchitis.PouchitisMedDRA version: 20.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000048-73-GBApplied Molecular Transport Inc.144
进行中（未招募）
1 期
A study of AMT-101 in patients with Pouchitis.PouchitisMedDRA version: 20.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000048-73-FRApplied Molecular Transport Inc.144
进行中（未招募）
1 期
A study of AMT-101 in patients with Pouchitis.PouchitisEUCTR2020-000048-73-NLApplied Molecular Transport Inc.144
已完成
2 期
A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitisinflammatory bowel disease10017969PouchitisNL-OMON52357Applied Molecular Transport Inc.12