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临床试验/NL-OMON54627
NL-OMON54627已完成3 期

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn*s Disease - Study of Ozanimod as Maintenance Therapy in patients with Crohn*s Disease

Celgene International II Sàrl0 个研究点目标入组 2 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
2
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. Subject fulfilled the inclusion criteria at time of entry into the Induction
  • •Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy
  • •assessments of the Induction Study.
  • •2. Subject should not have any constraints under local regulations, must
  • •provide written informed consent prior to any study-related procedures, and
  • •must have the ability to comply with the Table of Events.
  • •3. Subject is in clinical response (a reduction from baseline in CDAI of >= 100
  • •points or CDAI score of < 150 points) and/or in clinical remission based on an
  • •average daily stool frequency score <= 3 with abdominal pain and stool frequency
  • •no worse than baseline and an average abdominal
  • •pain score <= 1 and/or CDAI score of < 150 points at Week 12 of the Induction
  • •4. Female subjects of childbearing potential (FCBP):
  • •Note: For the purposes of this study, a female subject is considered to be of
  • •childbearing potential if she 1) has not undergone a hysterectomy (the surgical
  • •removal of the uterus) or bilateral oophorectomy (the surgical removal of both
  • •ovaries) or 2) has not been postmenopausal for at least 24 consecutive months
  • •(that is, has had menses at any time during the preceding 24 consecutive
  • •months). Must agree to practice a highly effective method of contraception
  • •throughout the study 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. Examples of acceptable methods of birth
  • •control in the study are the following:
  • •combined hormonal (containing oestrogen and progestogen) 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
  • •vasectomized partner
  • •complete sexual abstinence
  • •Periodic abstinence (calendar, symptothermal, post-ovulation methods),
  • •withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea
  • •method are not acceptable methods of contraception. Counseling about pregnancy
  • •precautions and the potential risks of fetal exposure must be conducted for
  • •FCBP. The Investigator will educate all FCBP about the different options of
  • •contraceptive methods or abstinence at Day 1, as appropriate. The subject will
  • •be re-educated every time her contraceptive measures/methods or ability to
  • •become pregnant changes. The female subject's chosen form of contraception must
  • •be effective by the time the female subject is randomized into the study (for
  • •example, hormonal contraception should be initiated at least 28 days before
  • •randomization).

排除标准

  • •Exclusions Related to General Health:
  • •1. Subject has any clinically relevant cardiovascular, hepatic,
  • •neurological, pulmonary (severe respiratory disease [pulmonary fibrosis
  • •or chronic obstructive pulmonary disease]), ophthalmological,
  • •endocrine, psychiatric, or other major systemic disease making
  • •implementation of the protocol or interpretation of the study difficult or
  • •that would put the subject at risk by participating in the study.
  • •2. Subject is pregnant, lactating, or has a positive urine beta human
  • •chorionic gonadotropin (ß-hCG) test measured prior to randomization.
  • •3. Subject has suspected or diagnosed intra-abdominal or perianal
  • •abscess that has not been appropriately treated.
  • •4. Subject has undergone a colectomy (partial or total), small bowel
  • •resection, or an ostomy (ie, temporary colostomy, permanent colostomy,
  • •ileostomy, or other enterostomy) since Day 1 of the Induction Studies or
  • •has developed symptomatic fistula (enterocutaneous or entero enteral).
  • •5. Subject has had cancer within 5 years including solid tumors and
  • •hematological malignancies (except basal cell and in situ squamous cell
  • •carcinomas of the skin or cervical dysplasia/cancer that have been
  • •excised and resolved); or colonic dysplasia that has not been completely
  • •Exclusions Related to Medications:
  • •6. Hypersensitivity to active ingredients or excipients of ozanimod or
  • •7. Subject has received any of the following therapies during the
  • •Induction Study:
  • •a. rectal steroid therapy (ie, steroids administered to the rectum or
  • •sigmoid via foam or enema)
  • •b. post-baseline (of induction) initiation of, or increase in,
  • •corticosteroids to treat worsening CD to a dose greater than the
  • •maximum daily dose taken between the screening and baseline visits
  • •c. rectal 5- aminosalicylates (ASA) (ie, 5-ASA administered to the
  • •d. parenteral corticosteroids > 14 days
  • •e. total parenteral nutrition therapy
  • •f. antibiotics for the treatment of CD
  • •g. immunomodulatory agents (6-MP, AZA, including but not limited to
  • •cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
  • •h. immunomodulatory biologic agents as well as other treatments for CD
  • •such as etrasimod, filgotinib, and upadacitinib
  • •i. investigational agents
  • •j. apheresis
  • •8. Subject has current or planned treatment with immunomodulatory
  • •agents (eg, AZA, 6-MP, or MTX) during the Maintenance Study.
  • •9. Subject has chronic nonsteroidal anti-inflammatory drug (NSAID) use
  • •(note: occasional use of NSAIDs and acetaminophen [eg, headache,
  • •arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day
  • •is permitted).
  • •10. Subject has received treatment with Class Ia or Class III
  • •antiarrhythmic
  • •drugs, treatment with 2 or more agents in combination
  • •known to prolong PR interval or treatment with additional prohibited
  • •systemic cardiac medication provided in Table 7.
  • •11. Subject has received a live or live attenuated vaccine within 4 weeks
  • 另有 8 项未显示

研究者

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