EUCTR2021-006656-14-BE进行中（未招募）1 期
Exploratory Study to Evaluate Safety, Mechanistic and Clinical Effects of MH002 in Subjects with Acute Pouchitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Male or female aged =18 years and =75 years
- •- Documented history of RPC with IPAA for UC performed at least 12 months prior to enrollment
- •- Confirmed diagnosis of Acute Pouchitis at Screening as defined by a modified Pouchitis Disease Activity Index (mPDAI) total score =5 and a mPDAI endoscopic subscore of =2 with symptoms not lasting >4 weeks
- •- Females of childbearing potential must not be pregnant or lactating and must agree to take an acceptable effective (or highly effective) contraceptive method of birth control during the study
- •- Written informed consent
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Chronic Pouchitis (=4 weeks of active Pouchitis) or antibiotic refractory Pouchitis
- •- Pelvic sepsis, macroscopic ulceration(s) of the pouch exclusively on the IPAA anastomotic line, anal sphincter dysfunction, Crohn’s Disease of the pouch (known or suspected), Irritable Pouch Syndrome, isolated cuffitis, clinically significant pouch complications (stricture, fistula, anastomotic leak), diverting stoma, fecal incontinence
- •- Evidence of systemic impact of Pouchitis, bacteremia or sepsis, fever (>37.8°C), or any active infection of the gastrointestinal (GI) tract (e.g., Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Cryptosporidium, Vibrio, Aeromonas, and Plesiomonas)
- •- Medical history of any GI cancer
- •- Any uncontrolled or unstable disorder (at the Investigator’s discretion, e.g., unstable Primary Sclerosing Cholangitis), including any clinically significant abnormality identified at Screening (e.g., safety lab parameters, physical exam) that may, according to the Investigator, put the subject at risk or interfere with the study procedures or reliability of study assessments to be done
- •-Prior use (since IPAA) of any biological treatment, including ustekinumab, anti-TNF agents (e.g., infliximab or adalimumab) or anti-integrin antibodies (e.g., vedolizumab), or treatment with small molecules such as ozanimod or any Janus kinase inhibitor (e.g., tofacitinib)
- •- Use of any topical treatment <4 weeks, any treatment with DiseaseModifying Antirheumatic Drugs (DMARDs) or other immunosuppressants, antibiotics, prebiotics or probiotics, or any investigational treatment <8 weeks, or Fecal Microbiota Transplantation <12 weeks prior to the Screening pouch endoscopy
- •- Concomitant use, during the study, of any prohibited medication: any anti-inflammatory agents (e.g., 5-ASA or systemically available corticosteroids), biologicals, immunosuppressants, DMARDs, Live
- •Biotherapeutic Products (LBPs, other than MH002), probiotics, prebiotics, antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (low dose aspirin excepted), investigational medicinal product (other than MH002) or investigational medical device, opioids or any rectally
- •administered medication
- •- Conditions linked to severe immunosuppression (e.g., related to human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy)
- •- Increased risk of developing infectious endocarditis including:
- •-Prosthetic cardiac valves including transcatheter-implanted prostheses and homografts,
- •-Prosthetic material used for cardiac valve repair such as annuloplasty rings and chords,
- •-Previous infectious endocarditis,
- •-Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device
- •- Any contraindication for pouch endoscopy
- •- Subject not being able, according to the Investigator, to reliably meet study requirements, e.g., planned major surgery or travelling during the study, or alcohol/illicit drug dependence
研究者
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