A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizu… (NCT07612267) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
United States, Canada, Denmark14 participantsStarted 2026-06
Plain-language summary
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
Participation in this study could last up to 94 days, including screening and follow-up period.
Who can participate
Age range
3 Weeks
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Study Participants:
* Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0
* Multiple births may be allowed following discussion with the medical monitor.
Note: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation
* Lactation history is well established, with the mother exclusively breastfeeding her infant
* Mother participant is receiving mirikizumab therapeutically for an approved diagnosis (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)
* Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula
Exclusion Criteria:
* Have a history of inadequate lactation, for multiparous participants who have previously breastfed
* Have a significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking mirikizumab, or of interfering with the interpretation of data
* Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered
* Have a history of breast augmentation procedures judged to have a clinical impact on breast milk expression such as breast reduction s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of Mirikizumab in Breast Milk
Timeframe: Predose up to 28 Days
Trial details
NCT IDNCT07612267
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-09
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or