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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2026
  • participants needed
    1200
  • sponsor
    Celgene
Updated on 22 February 2021
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Ahmed Kathrada Private Hospital (7.2 mi away) Contact
+807 other location
remission
crohn's disease

Summary

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Ozanimod
Clinical Study IdentifierNCT03467958
SponsorCelgene
Last Modified on22 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study
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
Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive
Subject must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events
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
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
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)
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)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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