Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years - 75 Years|
Inclusion Criteria: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. 2. Must be male or female subjects aged 18 to 75 years (at Pre-baseline), inclusive. 3. Subject must provide written informed consent prior to any study-related procedures, and have the ability to comply with the Table of Events. 4. 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.
Exclusion Criteria: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 Exclusions Related to Medications: Subject has received any of the following therapies since the first dose of IP in the prior ozanimod study: 1. treatment with a biologic agent as well as other treatments for CD such as etrasimod, filgotinib, upadacitinib 2. treatment with an investigational agent other than ozanimod 3. treatment with D-penicillamine, leflunomide, thalidomide, natalizumab, fingolimod or other S1P modulators 4. 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: 1. treatment with corticosteroids at a dose that exceeds the prednisone equivalent of >40 mg 2. 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kanthi Kollengode, MD|
|Principal Investigator Affiliation||Celgene|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Experimental: Administration of oral Ozanimod
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks
Drug: - Ozanimod
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.