EUCTR2020-004355-33-PL进行中（未招募）1 期
Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Mechanistic Effects, and Effects on Disease Activity of MH002 in Subjects with Mild to Moderate Ulcerative Colitis: A First-in-human Study - First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •1. Male or female aged =18 years and =75 years,
- •2. Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of UC at least 3 months prior to Screening (a biopsy report supporting the histologic diagnosis must be available),
- •3. Confirmed diagnosis of mild to moderate UC at Screening as defined by an MMS =4 but <8 and MES of 2 or 3(Central reading).
- •4. Left-sided colitis lesions =10 cm,
- •5. Subject should be receiving a stable dosing (topical or systemic) regimen of 5-ASA (eg, Asacol, Pentasa, Lialda, Apriso, Delzicol) =4 weeks prior to randomization and continue on that same regimen during the study,
- •6. Females of childbearing potential (FOCBP) must agree to utilize an acceptable effective or highly effective contraceptive method of birth control, eg, use a male or female condom with or without spermicide or any prescription hormonal contraceptive, during study participation at a minimum, and
- •7. Subject should provide 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Diagnosis of Crohn’s Disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon,
- •2. Evidence of a clinically significant, active infection of the gastrointestinal tract (eg, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Vibrio, Aeromonas, Plesiomonas, Cryptosporidium, and toxigenic Clostridium difficile) or of any other organ system at Screening, unless deemed benign (eg, mild common cold),
- •3. Ulcerative proctitis involving only the rectum,
- •4. Severe UC as per modified Truelove Witts’ criteria or patients in whom colitis is most severe in the transverse colon or ascending colon,
- •5. Total colectomy, stoma or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon,
- •6. Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC,
- •7. History of colon carcinoma or high-grade dysplasia or absence of total endoscopy =18 months in a subject suffering from UC =8 years,
- •8. Previous use of any anti-TNF (eg, Infliximab), anti-integrin antibodies (eg, Entyvio) or Janus kinase inhibitors (eg, tofacitinib),
- •9. Use of sulfasalazine =4 weeks prior to randomization into the study,
- •10. Use of corticosteroids or any disease-modifying antirheumatic drug (DMARD), including thiopurines (eg, Imuran) =6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (=8 mg methylprednisolone/day or equivalent) for at least 2 weeks prior to colonoscopy and remaining on the same dose up to Visit 8/EDV,
- •11. Conditions linked to severe immunosuppression (eg, human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy),
- •12. Leukopenia (total white blood cell count <3500/µL) and/or neutropenia (absolute neutrophil count <1500/µL),
- •13. Severe anemia (hemoglobin <10 g/dL),
- •14. Thrombocytopenia (peripheral blood platelet count <100 × 109/L), or any coagulation disorder with significantly increased risk of bleeding,
- •15. Ongoing or recent (<3 months), significant renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate significantly outside normal limits for age and sex,
- •16. Ongoing or recent (<3 months), significant hepatic disease as manifested by medical history and/or clinical examination and/or an increase in 2.5 × the upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transpeptidase, or alkaline phosphatase,
- •17. Clinically significant bone marrow disease if progressive or not controlled,
- •18. Any protein-losing enteropathy (any cause),
- •19. Any systemic (autoimmune) disease if progressive or not controlled (uncomplicated and well-controlled diabetes mellitus is allowed),
- •20. Any granulomatous disease,
- •21. 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, and
- •- 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
- •22. Any history of solid organ or bone marrow transplantation,
- •23. Use of antibiotics (except for local use), prebiotics, or probi
研究者
相似试验
进行中（未招募）
1 期
First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitislcerative ColitisMedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-004355-33-CZMRM Health NV45
进行中（未招募）
1 期
First-in-human Study of MH002 in Subjects with Mild to Moderate Ulcerative Colitislcerative ColitisMedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-004355-33-BEMRM Health NV45
进行中（未招募）
1 期
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk PregnanciesFetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)MedDRA version: 20.1Level: PTClassification code: 10075149Term: Neonatal alloimmune thrombocytopenia Class: 100000004850CTIS2023-504307-88-00Janssen - Cilag International38
进行中（未招募）
不适用
Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children with Attention Impairment Following Cancer TreatmentEUCTR2007-005435-28-NLEisai Limited300
进行中（未招募）
1 期
Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children with Attention Impairment Following Cancer TreatmentAttention impairment after cancer treatmentEUCTR2007-005435-28-FREisai Limited71