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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

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, 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.
3.Subject should not have any constraints under local regulations, must provide written informed consent prior to any study-related procedures, and must have the ability to comply with the Table of Events.
4.Female subjects of childbearing potential (FCBP):
Note: For the purposes of this study, a female subject is considered to be of childbearing potential if she 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
•vasectomized partner
•complete sexual abstinence
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.
Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted for FCBP. 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 Day 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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 cardiovascular hepatic, neurological, pulmonary (severe respiratory disease (pulmonary fibrosis or chronic obstructive pulmonary disease) 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) test
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 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 or 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)
•treatment with a live or line 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, AZA, 6-MP, or MTX)
•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 or treatment with additional prohibited systemic cardiac medication
•treatment with breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine, eltrombopag)
8. Subject is receiving treatment with any of the following drugs or interventions:
- CYP2C8 inducers (eg, rifampicin)
- Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
4.3.3. Exclusions Related to Laboratory Results and Other Assessments:
9. Subjects has a pre-dose resting HR < 55 bpm. One recheck is allowed at the Day 1 visit. If HR remains < 55 bpm at Day 1, one additional
recheck is allowed at a later date within the available window for roll over from the previous study.

Study & Design

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