Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

A PHASE 3, MULTI CENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE

Keywords

Crohn Disease Crohn's Disease Oral Ozanimod Moderately active Severely active RPC01 RPC01-3204 Administration of oral Ozanimod

Eligibility

You can join if…

Open to people ages 18-75

Subjects must satisfy the following criteria to be enrolled in the study:

  1. 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.

You CAN'T join if...

The presence of any of the following will exclude a subject from enrollment:

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 (β-hCG)
  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:

  1. Subject has received any of the following therapies since the first dose of IP in the prior ozanimod study:
  2. treatment with a biologic agent
  3. treatment with an investigational agent other than ozanimod
  4. treatment with D-penicillamine, leflunomide, thalidomide, natalizumab or fingolimod
  5. treatment with lymphocyte-depleting therapies (eg, Campath®, anti-CD4,cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
  6. treatment with a live 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:
  8. treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg
  9. treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate)
  10. 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)
  11. treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval
  12. Subject has ECG results showing any clinically significant abnormality on the last ECG of the previous study
  13. Liver function impairment or persisting elevations of aspartate aminotransferase (AST)or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
  14. Subject has a forced expiratory volume (FEV1) at 1 second or forced vital capacity(FVC) < 50% of predicted values.
  15. . Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL.

Locations

  • UCSD Medical Center not yet accepting patients
    La Jolla California 92037 United States
  • San Diego Clinical Trials accepting new patients
    San Diego California 92120 United States
  • Medical Associates Research Group accepting new patients
    San Diego California 902123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03467958
Phase
Phase 3
Study Type
Interventional
Last Updated