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: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004295-55-SE
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-08
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1350

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 must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events. For adolescents, a parent/legal guardian of the adolescent must sign the informed consent form. In addition, adolescent subjects must also agree to participate in the study by signing an assent form. A parent or guardian must be willing to supervise adherence to the protocol requirements. Adolescent subjects who reach the legal age of consent while participating in the study will be asked to sign an ICF themselves to acknowledge their willingness to continue in the study.
3. Female subjects of childbearing potential:
Note: For the purposes of this study, a female subject is considered to be of childbearing potential if she is = 12 years of age or has reached menarche, whichever occurred first, and 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 had menses 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
• vasectomised 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 female subjects of childbearing potential. 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 D

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 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 (ß-hCG)
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, 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)
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:
8. Subject has any clinically significant abnormality ECG results which in the opinion of the investigator may put the subject at risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified