Clinical Trials List
2019-03-01 - 2026-12-31
Phase III
Recruiting5
ICD-10K56.69
Other intestinal obstruction
ICD-10K50.90
Crohn's disease, unspecified, without complications
ICD-10K50
Crohn's disease [regional enteritis]
ICD-9560.89
Other specified intestinal obstruction
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
Celgene International II Sàrl
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Trial scale
Multi-Regional Multi-Center
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Update
2023/03/10
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 康瑞文 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 陳介章 Digestive System Department
- Ming-Shiang Wu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Chien-Yu Lu Digestive System Department
- Wen-Hung Hsu Digestive System Department
- Deng-Chyang Wu Digestive System Department
- Fang-Jung Yu Yu Digestive System Department
- Yu-Chung Su Digestive System Department
- I-CHEN WU Digestive System Department
- Chao-Hung Kuo Digestive System Department
- HSIANG YAO SHIH Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Taiwan National PI
Co-Principal Investigator
- Ming-Yao Su Digestive System Department
- Puo-Hsien Le Digestive System Department
- Chia-Jung Kuo Digestive System Department
- 林偉彬 Digestive System Department
- Cheng-Yu Lin Digestive System Department
- 許振銘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution 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 in the
Maintenance Study RPC01-3203, subjects who complete the Maintenance Study RPC01-3203,
subjects who complete at least 1 year of RPC01-2201, subjects who complete Study
RPC01-1201, and subjects who complete a study of ozanimod for CD 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. (per regulation, in Taiwan this study is open to patients aged 20-75 only)
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. (1) 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
(2) 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.
(3) 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. Hypersensitivity to active ingredients or excipients of ozanimod
6. 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 or live attenuated vaccine within 4 weeks prior to Day 1 of this study
7. 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
treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine,
eltrombopag)
8. Subject is receiving treatment with any of the following drugs or interventions within the
corresponding timeframe:
- At Day 1
o CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) and inducers (eg, rifampicin)
- Two weeks prior to Pre-baseline
o Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
Exclusions Related to Laboratory Results:
9. Subject has ECG results showing any clinically significant abnormality on the last ECG of the previous study
10. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
11. Subject has a forced expiratory volume (FEV1) at 1 second or forced vital capacity (FVC) < 50% of predicted values.
The Estimated Number of Participants
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Taiwan
9 participants
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Global
1200 participants
