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Mirikizumab Levels in Breast Milk for Lactating Mothers with Inflammatory Bowel Disease

This study is looking at how much mirikizumab, a medication for inflammatory bowel disease, gets into breast milk. We want to understand this for mothers who are breastfeeding and already taking mirikizumab. You may be able to join if you are at least 18 years old, breastfeeding, and your baby is at least 3 weeks old. The main goal is to measure the concentration of mirikizumab in your breast milk. The study aims to enroll 14 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 14 participants.
What's involved
Your participation in this study could last up to 94 days, including screening and follow-up periods.
Compensation
Not stated in the trial record.
Follow-up
Mirikizumab levels in breast milk will be measured from before you take your dose up to 28 days later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07612267

A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

Recruiting
PHASE4Ages 3+Interventional
Eli Lilly and Company
~14 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Mirikizumab

At a glance

Recruiting sites
1 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of Mirikizumab in Breast Milk
Measured over Predose up to 28 Days

Conditions

Lactation
Inflammatory Bowel Disease

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Where it's being run

20 sites across 11 states
Israel4
Italy4
Denmark2
Germany2
Poland2
Illinois1
Iowa1
Maryland1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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 surgery and some breast implants, or current evidence of acute or chronic conditions affecting breasts and potentially interfering with breast milk collection
Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before enrollment or intend to receive a live vaccine during the study or an inactivated vaccine 2 weeks postdose, the mother participant must be given the vaccine at an injection site remote from mirikizumab administration

What this trial measures

  • Concentration of Mirikizumab in Breast MilkPredose up to 28 Days