Join the study to help learn about the safety of using Zeposia® (ozanimod) while breastfeeding. A lactation study collects health information and samples from breastfeeding individuals taking prescription medicines and their breastfed infants.
You may be eligible to join the study if you:
If you are eligible and would like to participate, you will be asked to:
Both study visits are home visits. This means that the study staff will work with you to schedule a time for a home health nurse to come visit your home to collect information and samples as described below.
You will be paid $150 per visit (up to $600 total) for the time and effort of providing data and samples to the study.
If you are interested in being in this study, you will be given additional information about what to expect in the study and a chance to ask any questions you might have before you enroll.
Screening Visit (Visit 1)
At the screening visit (Visit 1), you will be asked to give information and samples to make sure that you meet all the requirements to be in the study. This will include demographic information, height and weight, medical history, information about any medications you used to take or are taking right now, any procedures/surgeries you have had, pregnancy history and any problems you had during birth or after you gave birth, breastfeeding history, and smoking history.
You will also have a physical exam, vital signs (heart rate, blood pressure, breathing, temperature), and a 12-lead echocardiogram (ECG), unless you have already had an ECG in the last 6 months before the study. Finally, a blood and urine sample will also be collected. You will also be asked to give information about your infant’s medical history, as well as any medications they have been given before or are currently getting and any medical procedures they have had. A blood sample will also be collected from your infant using a heel stick. The heel stick is a commonly used way to collect small amounts of blood from a baby. It is the same type of blood collection that is often used in the hospital for newborn screening after you gave birth.
At the time of Visit 1, you will also be given an electric milk pump, along with instructions on how to use it. You will need this to provide your milk sample at the second study visit. You will be able to keep the breast pump after the completion of the study.
Study Visit 2
If you meet all the requirements for being in the study, your second study visit will be about 3 months after the first visit and after you have been taking ozanimod for at least 55 days.
At this visit, your weight and information about any changes in medications/procedures you have had since the first visit will be collected again. You will have a shorter physical exam and vital signs will be collected again. Blood and urine samples will also be collected again.
At this visit you will also provide breast milk samples. You will be given instructions ahead of time about when to begin pumping your milk and how to collect it. Briefly, before your next scheduled dose, you will provide a single blood and milk sample. Then, after your dose, you will pump and store all of your milk for the next 24 hours in set intervals of about 4-6 hours.
You will again also be asked to provide information for your infant about any changes in medications or procedures that have taken place since last visit. A second blood sample will also be collected from your infant at this time using the same heel stick method as the first visit.
For this visit, a home health nurse may come to your house multiple times over the roughly 26 hours that you are pumping milk to collect your breast milk samples for shipment.
Safety Follow-Up
At roughly 30-40 days after your second study visit, one of the study staff will call you to follow-up and ask questions about whether you or your infant have experienced any adverse events since the last study visit. They will also again for any updates to medications or procedures for both you and your infant that have occurred since the last visit. If you discontinued taking ozanimod after the second visit and before the phone call, a safety follow-up will be conducted 90 to 100 days after the date you last received a dose of ozanimod.
Fill out the Contact Request form here and a study team member will contact you
Call the study team voice mailbox toll-free at
877-223-3576 followed by the World Reach Number code of 51003. You can call and leave your contact information at any time of the day or night. Your call will be returned during business hours 8:30 AM-5:00 PM EST Monday-Friday.
Zeposia® (ozanimod) is a prescription medicine made by Celgene International II Sàrl that is currently used to treat multiple sclerosis and ulcerative colitis in adults.
It is for the:
The information and samples that you provide in this study will help future breastfeeding individuals with multiple sclerosis or ulcerative colitis, their doctors, and researchers.