EUCTR2015-003364-36-BG进行中（未招募）1 期
A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active 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
- 40
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
- •1. Subject is = 18 years of age at the time of signing the ICF.
- •2. Subject is able to understand and voluntarily sign an ICF prior to conducting any studyrelated assessments/procedures.
- •3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •4. Subject must have a diagnosis of UC with a duration of at least 3 months prior to screening.
- •5. Subject must have moderate to severe UC, defined as MMS = 4 to = 9 with RBS = 1 at screening.
- •6. Subject must have a Mayo endoscopic subscore = 2 at screening.
- •7. Subject must have failed or experienced intolerance to at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, 6-mercaptopurine [6-MP], or azathioprine [AZA], or TNF-a blockers (eg, infliximab, adalimumab, or golimumab).
- •8. Subject must meet the following laboratory criteria:
- •a. White blood cell count = 3000/mm3 (= 3.0 X 10 9/L)
- •b. Platelet count = 100,000/mm3 (= 100 X 10 9/L)
- •c. Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
- •d. Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT])
- •and alanine transaminase (ALT/serum pyruvic transaminase [SGPT]) = 2.5 X upper limit of normal (ULN)
- •e. Total bilirubin = 2 mg/dL (= 34 µmol/L) unless there is a confirmed diagnosis of Gilbert's disease
- •f. Hemoglobin = 9 g/dL (= 5.6 mmol/L)
- •g. Activated partial thromboplastin time (APTT) = 1.5 X ULN
- •9. Females of childbearing potential (FCBP1) must have a negative pregnancy test at the Screening and Baseline Visits. While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- •Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner’s vasectomy;
- •Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm
- •with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- •10. Male subjects (including those who have had a vasectomy) when engaging in sexual activity with females who are able to become pregnant must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Subject has a diagnosis of CD, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- •2. Subject has ulcerative colitis restricted to distal 15 cm or less (eg, ulcerative proctitis).
- •3. Subject had surgery as a treatment for UC or who, in the opinion of the Investigator, is likely to require surgery for UC during the study.
- •4. Subject has clinical signs suggestive of fulminant colitis or toxic megacolon.
- •5. Subject is stool positive for any enteric pathogen or Clostridium difficile (C. difficile) toxin at screening.
- •6. Subject has history of colorectal cancer or colorectal dysplasia.
- •7. Prior treatment with more than 2 TNF-a blockers (eg, infliximab, adalimumab, or golimumab).
- •8. Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).
- •9. Use of TNF-a blockers within 8 weeks of the screening.
- •10. Subject had prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) for the treatment of UC. In addition, prior use of any of these treatment modalities for an indication other than UC within 8 weeks of screening is also excluded.
- •11. Subject has received intravenous (IV) corticosteroids within 2 weeks of screening.
- •12. Subject has received topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of screening.
- •13. Subject has received total parenteral nutrition (TPN) within 4 weeks of screening.
- •14. Subject has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would prevent the subject from participation in the study.
- •15. Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study.
- •16. Subject is pregnant or breastfeeding.
- •17. Subject has a history of any of the following cardiac conditions within 6 months of screening: myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, or presence of implanted defibrillator.
- •18. Subject has a known active current or history of medically important recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease and Herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
- •19. Subject has a history of congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
- •20. Subject has a history of malignancy, except for:
- •a. Treated (ie, cured) basal cell or squamous cell in situ skin carcinomas
- •b. Treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
- •21. Subject has received investigational drug or device within 1
研究者
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