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(352) 733-0111

RPC01-3204

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Details

Full study title A Phase 3, Multi Center, Open-Label Extension Study Of Oral Ozanimod For Moderately To Severely Active Crohn's Disease
Protocol number OCR24242
ClinicalTrials.gov ID NCT03467958
Phase Phase 3

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

Visit: www.BmsstudyConnect.com

Inclusion Criteria:

  • Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies

  • Experience relapse or who complete the Maintenance Study

  • Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion Criteria:

  • 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

  • Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated

  • Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Alexandra Emile-Reynolds
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.