An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Inclusion Criteria:

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

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 75-day 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.

Exclusion Criteria:

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.