EUCTR2017-004295-55-BE进行中（未招募）1 期
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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. Subjects who are not in clinical response and/or clinical remission
- •after completing 12 weeks in the Induction Studies RPC01-3201 or
- •RPC01-3202, subjects who experience relapse in the Maintenance Study
- •RPC01-3203, subjects who complete the Maintenance Study RPC01-
- •3203, subjects who complete at least 1 year of RPC01 2201.
- •Subject should not have any constraints under local regulations, must
- •provide written informed consent prior to any studyrelated procedures,
- •and must have the ability to comply with the Table of Events.
- •3. 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.
- •Female condom and male condom should not be used together.
- •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 starts the study (for example, hormonal contraception
- •should be initiated at least 28 days before Day 1).
- •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 1080
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •The presence of any of the following will exclude a subject from
- •enrollment:
- •4.3.1. 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
- •3. Subject has suspected or diagnosed intra-abdominal or perianal
- •abscess that has not been appropriately treated
- •4.3.2. Exclusions Related to Medications:
- •4. Hypersensitivity to active ingredients or excipients of ozanimod
- •5. Subject has received any of the following therapies since the first dose
- •of IP in the prior ozanimod study:
- •treatment with a biologic agent as well as other treatments for CD
- •such as etrasimod, filgotinib, upadacitinib
- •treatment with an investigational agent other than ozanimod
- •treatment with D-penicillamine, leflunomide, thalidomide,
- •natalizumab, fingolimod or other S1P modulators
- •treatment with lymphocyte-depleting therapies (eg, Campath®, anti-
- •CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide,
- •mitoxantrone, total body irradiation, bone marrow transplantation,
- •alemtuzumab, daclizumab)
- •6. Subject is currently receiving or requires initiation of any of the
- •following therapies:
- •treatment with corticosteroids at a dose that exceeds the prednisone
- •equivalent of >40 mg
- •treatment with immunomodulatory agents (eg, AZA, 6-MP, or MTX)
- •chronic non-steroidal 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
- •treatment with Class Ia or Class III anti-arrhythmic drugs or treatment
- •with 2 or more agents in combination known to prolong PR interval, or
- •treatment with additional prohibited systemic cardiac medication
- •treatment with breast cancer resistance protein (BCRP) inhibitors (eg,
- •cyclosporine, eltrombopag)
- •7. Subject is receiving treatment with any of the following drugs or
- •interventions within the corresponding timeframe:
- •CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) and inducers (eg,
- •rifampicin)
- •Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
- •4.3.3. Exclusions Related to Laboratory Results and Other Assessments:
- •8. Subject has any clinically significant abnormal results (eg, labs or
- •ECG) which in the opinion of the Investigator may put the subject at risk.
- •9. Subjects has a pre-dose resting HR < 55 bpm. One recheck is allowed
- •at the Day 1 visit. If HR remains < 55 bpm at Day 1, one additional
- •recheck is allowed at a later date within the available window for rollover
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