NL-OMON45076已完成2 期
A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY<br>TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004)<br>FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS - Celgene CC-10004-UC-001
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female aged 18 and over at the time of signing the informed
- •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 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 until Week 104 for subjects who participate in the Extension Phase.
- •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 *mol/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 *mol/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
- 另有 5 项未显示
排除标准
- •1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis,
- •microscopic colitis, radiation colitis or diverticular disease-associated
- •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
- •4. Clinical signs suggestive of fulminant colitis or toxic megacolon.
- •5. Evidence of pathogenic enteric infection.
- •6. History of colorectal cancer or colorectal dysplasia (with the exception of adenomatous colonic polyps that have been completely resected).
- •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
- •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
- •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
- •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
- 另有 13 项未显示
研究者
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