NL-OMON47857已完成2 期
A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS - RPC01-202
Celgene International II Sarl (CIS II)0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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 99（—）
入选标准
- •1. Males or female patients aged 18 to 75 years, inclusive
- •2. Have had UC diagnosed at least 2 months prior to screening. The diagnosis of
- •UC must be confirmed by endoscopic and histologic evidence
- •3. Have active UC confirmed on endoscopy with >= 15 cm involvement
- •4. Have active UC defined as Mayo score of 6-12 inclusive with endoscopic
- •subscore of >= 2
- •5. Have undergone colonoscopy or sigmoidoscopy within the past 2 years for
- •extent of disease, and if the UC has been present for > 10 years, have had a
- •colonoscopy with biopsy to rule out dysplasia
- •6. Female patients of childbearing potential:
- •Must agree to practice a highly effective method of contraception throughout
- •the trial until completion of the 90-day safety follow-up visit. Highly
- •effective methods of contraception are those that alone or in combination
- •result in a failure rate of a Pearl index of less than 1% per year when used
- •consistently and correctly. Acceptable methods of birth control in the trial
- •are the following:
- •- Combined hormonal (oestrogen and progestogen containing) contraception, which
- •may be oral, intravaginal, or transdermal
- •- Progestogen-only hormonal contraception associated with inhibition of
- •ovulation, which may be oral, injectable, or implantable
- •- Placement of an intrauterine device (IUD)
- •- Placement of an intrauterine hormone-releasing system (IUS)
- •- Bilateral tubal occlusion
- •- Vasectomised partner
- •- Sexual abstinence
- •- Periodic abstinence (calendar, symptothermal, post-ovulation methods),
- •withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea
- •method are not acceptable methods of contraception.
- •7. Must be currently receiving treatment with at least 1 of the following
- •a. Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine,
- •balsalazide) for at least 6 weeks with the dose stable for at least 3 weeks
- •prior to screening endoscopy
- •b. Prednisone (doses <= 30 mg) or equivalent for at least 4 weeks and receiving
- •a stable dose for at least 2 weeks
- •8. If oral aminosalicylates or corticosteroids have been recently discontinued,
- •they must have been stopped for at least 2 weeks prior to the endoscopy used
- •for baseline Mayo Score
- •9. All patients aged 45 years or over must have had a colonoscopy to screen for
- •adenomatous polyps within 5 years of their first dose of investigational drug
- •or must have had a colonoscopy at screening to assess for polyps. The
- •adenomatous polyps must be removed prior to their first dose of investigational
- •10. Ability to provide written informed consent and to be compliant with the
- •schedule of protocol assessments
- •11. patients must have documentation of positive varicella zoster virus (VZV)
- •IgG antibody status or complete vaccination at least 30 days prior to
- •randomization.
- •12. Documentation of no evidence of chronic lung disease or tuberculosis (TB)
- •on a chest X-ray completed within the 6 months prior to screening. If a chest
- •x-ray was not done in the 6 months precreding the screening visit, it may be
- •performed during the screening visit.
排除标准
- •1. Have severe extensive colitis evidenced by:
- •- Physician judgment that patient is likely to require colectomy or ileostomy
- •within 12 weeks of baseline
- •- Current evidence of fulminant colitis, toxic megacolon or bowel perforation
- •- Previous total colectomy
- •- Have 4 or more of the following:
- •Temp > 38°C, Heart rate (HR) > 110 (bpm); Focal severe or rebound abdominal
- •tenderness; Anemia (hemoglobin < 8.5 g/dL); Transverse colon diameter > 5cm on
- •plain X-ray
- •2. Diagnosis of Crohn*s disease or indeterminate colitis or the presence or
- •history of a fistula consistent with Crohn*s disease
- •3. Have positive stool culture for pathogens (O+P, bacteria) or positive test
- •for C. difficile at screening. If C. difficile is positive, the patient may be
- •treated and retested
- •4. Have had treatment with cyclosporine, tacrolimus, sirolimus, or
- •mycophenolate mofetil (MMF) within 16 weeks of screening
- •5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin
- •(hCG) measured during screening
- •6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological,
- •endocrine, psychiatric or other major systemic disease making implementation or
- •interpretation of the study difficult or that would put the patient at risk
- •7. Clinically relevant cardiovascular conditions, including history or presence
- •i. Recent (within the last 6 months) occurrence of myocardial infarction,
- •unstable angina, stroke, transient ischemic attack, sick sinus syndrome,
- •decompensated heart failure requiring hospitalization, , Class III/IV heart
- •failure or severe untreated sleep apnea
- •ii. Prolonged a QTcF interval (QTcF > 450 msec males, > 470 msec females), or
- •at additional risk for QT prolongation (e.g. hypokalemia, hypomagnesemia,
- •congenital long-QT syndrome)
- •iii. Patients with other pre-existing stable cardiac conditions who have not
- •been cleared for the study by an appropriate cardiac evaluation by a
- •cardiologist.
- •8. Resting HR less than 55 beats per minute (bpm) when taking vitals as part of
- •a physical exam at screening.
- •9. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type
- •2 with hemoglobin A1c > 7%, or diabetic patients with significant co-morbid
- •conditions such as retinopathy or nephropathy.
- •10. History of uveitis
- •11. Known active bacterial, viral, fungal, mycobacterial infection or other
- •infection (including TB or atypical mycobacterial disease [excluding fungal
- •infection of nail beds]) or any major episode of infection that required
- •hospitalization/treatment with intravenous (IV) antibiotics within 30 days or
- •oral antibiotics within 14 days prior to screening
- •12. History or known presence of recurrent or chronic infection (e.g.,
- •hepatitis A, B, C or E, human immunodeficiency virus, syphilis, TB); recurring
- •urinary tract infections are allowed
- •13. History of cancer, including solid tumors and hematological malignancies
- •(except basal cell and in situ squamous cell carcinomas of the skin that have
- •been excised and resolved)
- •14. History of alcohol or drug abuse within 1 year prior to randomization
- 另有 4 项未显示
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