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临床试验/NL-OMON47446
NL-OMON47446已完成3 期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Receptos RPC01-3101

Celgene International II Sarl (CIS II)0 个研究点目标入组 33 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
33
研究概览入排标准研究者记录与标识符相似试验

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. Male or female patients aged 18 to 75 years (at screening), inclusive
  • •2. Have had UC diagnosed at least 3 months prior to first investigational drug administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (note: endoscopy and histopathology may be performed at Screening if no prior report is readily available).
  • •3. Evidence of UC extending * 15 cm from the anal verge as determined by Baseline
  • •endoscopy (flexible sigmoidoscopy or colonoscopy)
  • •4. Have active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore
  • •of * 2, a rectal bleeding score of * 1, and a stool frequency score * 1
  • •5. Must be currently receiving treatment with at least 1 of the following therapies and
  • •must continue on these therapies during Induction:
  • •* - Oral aminosalicylates at a therapeutic dose for their disease (eg, mesalamine,
  • •sulfasalazine, olsalazine, balsalazide), with the dose stable for at least 3 weeks,
  • •prior to Screening endoscopy
  • •* - Prednisone (doses * 20 mg per day) or equivalent receiving a stable dose for at
  • •least 2 weeks prior to Screening endoscopy
  • •* - Budesonide MMX therapy receiving a stable dose for at least 2 weeks prior to screening endoscopy.
  • •6. Have undergone colonoscopy (or are willing to undergo colonoscopy during Screening):
  • •- within the past 2 years, to screen for dysplasia (unless otherwise recommended by local and national guidelines) if the patient has had left-sided colitis of > 12 years duration or total / extensive colitis of > 8 years duration
  • •- within the past 5 years, to screen for polyps if the patient age is > 45 years
  • •7. 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
  • •8. Female patients of childbearing potential:
  • •Must agree to practice a highly effective method of contraception throughout the trial until completion of the 75- 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;Male patients:
  • •Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study until completion of the 75-day safety follow-up visit.;All patients:
  • •Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.
  • •Female condom and male condom should not be used together.
  • •9. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments
  • •10. Patients must have documentation of positive Varicella zoster virus IgG antib

排除标准

  • •1. Have severe extensive colitis as evidenced by:
  • •* Physician judgment that the patient is likely to require colectomy or ileostomy
  • •within 12 weeks of Baseline
  • •* Current or recent (within 3 months) evidence of fulminant colitis, toxic
  • •megacolon, or bowel perforation
  • •2. Diagnosis of Crohn*s disease or indeterminate colitis or the presence or history of
  • •a fistula consistent with Crohn*s disease or microscopic colitis or radiation colitis or
  • •ischemic colitis
  • •3. Have positive stool examination for pathogens (ova and parasites, bacteria) or
  • •positive test for toxin producing Clostridium difficile (C. difficile) at Screening. PCR (polymerase chain reaction) examination of the stool for C. difficile may be used to excude false positives. If positive, patients may be treated and retested. Documentation of a negative test result for pathogens (ova and parisites, bacteria) is required within 60 days of Day 1.
  • •4. Pregnancy, lactation, or a positive serum *-human chorionic gonadotropin (*-hCG) measured during Screning
  • •5. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine,
  • •psychiatric, or other major systemic disease making implementation of the protocol or
  • •interpretation of the trial difficult or that would put the patient at risk by participating
  • •in the trial
  • •6. Clinically relevant cardiovascular conditions, including history or presence of:
  • •* Recent (within the last 6 months) occurrence of myocardial infarction, unstable
  • •angina, stroke, transient ischemic attack, decompensated heart failure requiring
  • •hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe
  • •untreated sleep apnea
  • •* Prolonged Fridericia's corrected QT interval (QTcF; QTcF > 450 msec
  • •for males, > 470 msec for females), or at additional risk for QT interval
  • •prolongation (eg, hypokalemia, hypomagnesemia, congenital long-QT
  • •* Resting HR < bpm when taking vital signs as part of a physical exam at
  • •7. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with
  • •glycosylated Hb (HbA1c) > 9% , or diabetic patients with significant comorbid
  • •conditions such as retinopathy or nephropathy
  • •8. History of uveitis (within the last year) or macular edema
  • •9. Known active bacterial, viral, fungal, mycobacterial infection, or other infection
  • •(including tuberculosis or atypical mycobacterial disease [but excluding fungal
  • •infection of nail beds, minor upper respiratory tract infections and minor skin
  • •infections]) or any major episode of infection that required hospitalization or
  • •treatment with intravenous antibiotics within 30 days of Screening or oral antibiotics
  • •within 14 days of Screening
  • •10. History of cancer, including solid tumors and hematological malignancies (except
  • •basal cell and in situ squamous cell carcinomas of the skin or uterine cervix that have
  • •been excised and resolved) or colonic mucosal dysplasia
  • •11. History of alcohol or drug abuse within 1 year prior to randomization;Exclusions Related to Medications:;12. History of treatment with a biologic agent within 8 weeks or 5 elimination half-lives (whichever is less) of that agent prior to randomization
  • •13. History of treatment with an investigational agent within 5 elimination half-lives of
  • •that agent prior to randomization
  • •14. History of treatment with topical rectal 5-aminosalicyli

研究者

发起方
Celgene International II Sarl (CIS II)

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