EUCTR2014-002981-64-HU进行中（未招募）不适用
A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 165
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. Male or female aged 18 and over at the time of signing the informed consent.
- •2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- •3. Must be able to adhere to the study visit schedule and other protocol requirements.
- •4. Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit
- •5. TMS = 6 to = 11 (range: 0-12) prior to randomization in the study.
- •6. Endoscopic subscore = 2 (range: 0-3) on the Mayo score prior to randomization in the study.
- •7. Subjects are required to have a colonoscopy if not performed within 12 months of the Screening Visit
- •8. Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).
- •9.Subjects receiving oral corticosteroids may continue their use during the study, provided that the dose (prednisone = 20 mg/day or equivalent, budesonide = 9 mg/day) has been stable for 3 weeks prior to the Screening Visit. If oral corticosteroids were recently discontinued, discontinuation must have been completed at least 3 weeks prior to the Screening Visit. Corticosteroid doses should remain stable until the subject is eligible to start corticosteroids tapering, beginning at the Week 12 Visit.
- •10. Oral aminosalicylates are permitted during the study, provided that treatment started at least 6 weeks prior to randomization with a stable dose of at least 14 days prior to the Screening Visit. The dose of oral aminosalicylates must remain stable through Week 52 or early termination from the study.
- •11. Must meet the following laboratory criteria:
- •- White blood cell count = 3000/mm3 (= 3.0 X 10E9/L) and < 14,000/mm3 (< 14 X 10E9/L)
- •- Platelet count = 100,000/mm3 (= 100 X 10E9/L)
- •- Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
- •- AST (SGOT) and ALT (SGPT) =2 X upper limit of normal (ULN). If initial test shows ALT or AST > 2 times the ULN, one repeat test is allowed during the screening period
- •- Total bilirubin = 2 mg/dL (= 34 µmol/L) or albumin > lower limit of normal (LLN). If initial test result is > 2 g/dL, one repeat test is allowed during the screening period
- •- Hemoglobin = 9 g/dL (= 5.6 mmol/L)
- •12. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and the Baseline Visit. 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 options2 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 (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide
- •13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] memb
排除标准
- •1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
- •2. Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
- •3. Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
- •4. Clinical signs suggestive of fulminant colitis or toxic megacolon.
- •5. Evidence of pathogenic enteric infection.
- •6. History of colorectal cancer or colorectal dysplasia.
- •7. Prior use of any TNF inhibitor (or any biologic agent).
- •8. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
- •9. Use of IV corticosteroids within 2 weeks of the Screening Visit
- •10. Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
- •11. Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2
- •weeks of the Screening Visit
- •12. 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 preclude
- •participation in the study.
- •13. Prior history of suicide attempt at any time in the subject’s lifetime prior to
- •randomization in the study or major psychiatric illness requiring hospitalization within 3
- •years of study randomization.
- •14. 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.
- •15. Pregnant or breast feeding.
- •16. 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.
- •17. Known active current or history of 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 intravenous (IV) or oral
- •antibiotics within 4 weeks of screening.
- •18. Subjects with active hepatitis B infection as described in Appendix E are ineligible for
- •the study. Subjects without current hepatitis B infection, as described in Appendix F, may
- •participate in the study.
- •19. Subjects who are positive for the hepatitis C antibody are not eligible for the study.
- •20. History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
- •21. 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 (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
- •22. Any condition that could affect oral drug absorption, including gastric resections,
- •gastroparesis or bariatric surgery, such as gastric bypass.
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