A PHASE 3, MULTI CENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE
This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.
18 Years to 75 Years
Accepting Healthy Volunteers?
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subjects who are not in clinical response or clinical remission after completing 12 weeks in the Induction Studies RPC01-3201 or RPC01-3202, subjects who experience relapse or who complete the Maintenance Study RPC01-3203, and subjects who complete a study of ozanimod for Crohn's Disease and meet the criteria for participation in the RPC01-3204 Study will have the opportunity to participate in this study.
2. Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive.
3. Subject must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events.
4. Female subjects of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study 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 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
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.
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.
The presence of any of the following will exclude a subject from enrollment:
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 (β-hCG)
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
Exclusions Related to Medications:
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
- treatment with an investigational agent other than ozanimod
- treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or fingolimod
- treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
- treatment with a live vaccine within 4 weeks prior to Day 1 of this study
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, azathioprine, 6-MP, or methotrexate)
- 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
7. Subject has ECG results showing any clinically significant abnormality on the last ECG of the previous study
8. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
9. Subject has a forced expiratory volume (FEV1) at 1 second or forced vital capacity (FVC) < 50% of predicted values.
10. Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL.