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

Overview

About this study

The purpose of this extension study is to evaluate the safety and effectiveness of ozanimod in subjects with moderately to severely active Crohn's Disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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; 
  • 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.

Exclusion Criteria:

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.
  • Subject is pregnant, lactating, or has a positive urine beta human chorionic gonadotropin (β-hCG).
  • Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
  • Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema.

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;
    • 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 vaccine within 4 weeks prior to Day 1 of this study.
  • 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.
  • Subject has ECG results showing any clinically significant abnormality on the last ECG of the previous study.
  • Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN).
  • Subject has a forced expiratory volume (FEV1) at 1 second or forced vital capacity (FVC) < 50% of predicted values.
  • Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Michael Van Norstrand, M.D., Ph.D.

Open for enrollment

Contact information:

Jodi Kaseno

(608) 392-7187

Kaseno.Jodi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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