What is a clinical research study?
A clinical research study, also known as a clinical trial, is a carefully designed study in which participants are asked to take an investigational drug under the supervision of a study doctor and other healthcare professionals. The investigational drug may or may not make you feel better. Every study participant is monitored with medical tests and study-related exams before, during, and sometimes even after the study.
Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and safety of study participants.
What should I expect as a participant?
Before you participate in a research study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “informed consent document” and discussed with you. You will be asked to review and sign the informed consent document prior to participating. Your medical history will be reviewed, and you will have a study-related medical examination and laboratory tests.
If you qualify, you may be enrolled in the study. Once enrolled, feel free to discuss your research care with the study doctor or research staff members at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the investigational drug being approved by the FDA or other regulatory health authorities, and may result in future developments of new drugs.
It is important for you to:
- Attend all scheduled visits
- Be truthful about your medical history
- Describe your feelings and well-being accurately and honestly to the study doctor
- Discuss any questions regarding the study with the study doctor
- Use the investigational drug as prescribed
As a study participant, you will have the right to contact the study’s institutional review board (IRB) or ethics committee (EC) representative regarding your rights as a research participant. You will also have the right to leave the study at any time.
What is the study drug?
Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. Selective binding with S1PR1 receptors is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.
Ozanimod is an investigational compound that is not approved for any use in any country.
See if you qualify