A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely 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.
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
Exclusions Related to Medications:
Subject has received any of the following therapies since the first dose of IP in the prior ozanimod study:
1. treatment with a biologic agent as well as other treatments for CD such as etrasimod, filgotinib, upadacitinib
2. treatment with an investigational agent other than ozanimod
3. treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod or other S1P modulators
4. treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
Subject is currently receiving or requires initiation of any of the following therapies:
1. treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg
2. treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate)
Exclusions Related to Laboratory Results:
Subject has any clinically significant abnormality ECG results which in the opinion of the investigator may put the subject at risk.