EUCTR2017-004294-14-ES进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 485
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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •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 must provide written informed consent prior to any study-related procedures and 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) or in clinical remission based on an average stool frequency score =< 3 with a stool frequency no worse than baseline and an average abdominal pain score =< 1 or CDAI score of < 150 points at Week 12 of the Induction Study.
- •4. Female subjects of childbearing potential:
- •Must agree to practice a highly effective method of contraception throughout the study until completion of the 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 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
- •- Vasectomised partner
- •- Sexual abstinence
- •Male subjects:
- •Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study until completion of the safety follow-up visit.
- •All subjects:
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Exclusions Related to General Health:
- •1. Subject has any clinically relevant hepatic, neurological, pulmonary, 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) measured prior to randomization.
- •3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
- •4. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema.
- •5. 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).
- •6. Subject has had active 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 removed.
- •Exclusions Related to Medications:
- •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. rectal 5-ASA (ie, 5-ASA administered to the rectum)
- •c. parenteral corticosteroids
- •d. total parenteral nutrition therapy
- •e. antibiotics for the treatment of CD
- •f. immunomodulatory agents (6-MP, azathioprine, including but not limited to
- •cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
- •g. immunomodulatory biologic agents
- •h. investigational agents
- •i. apheresis
- •8. Subject has current or planned treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate) 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 anti-arrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval.
- •11. Subject has received a live vaccine within 4 weeks prior to first dose of IP.
- •12. Subject has received previous treatment with lymphocyte-depleting therapies (eg, Campath™, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, or daclizumab).
- •13. Subject has received previous treatment with D-penicillamine, leflunomide or thalidomide.
- •14. Subject has received previous treatment with natalizumab or fingolimod.
- •15. Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of first dose of IP.
- •16. Subject has a history of treatment with IV immune globulin (IVIg), or plasmapheresis, within 3 months prior to first dose of IP.
- •Exclusions Related to Laboratory Results:
- •17. Subject has ECG results showing any clinically significant abnormality at Week 12 of the Induction Study.
- •18. Subject has confirmed aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the ULN
- •19. Subject has a forced expiratory volume at 1 seco
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