Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease

Phase 1

Conditions: Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-004295-55-AT

Lead Sponsor: Celgene International II Sàrl

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

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.
2. 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 hadmenses 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

Exclusion Criteria

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
permitted)
• 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 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 roll-over from previous study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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