Breast milk mirikizumab levels in lactating people using mirikizumab for IBS/IBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4, interventional study measures the concentration of mirikizumab in the breast milk of lactating participants who are receiving maintenance mirikizumab for an approved indication. Participants will be monitored for up to 94 days, including screening and follow-up. Eligible mothers must be at least 18 years old, exclusively breastfeeding, and have a breastfed infant who can feed from a bottle with stored milk or formula; infants must be at least 3 weeks old at Study Day 0. The study involves a single intervention of mirikizumab and is conducted at sites in Illinois, Iowa, and Maryland.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, Israel Recruiting
• Tel Aviv Sourasky Medical Center Ichilov - PPDS
  Tel Aviv, Israel Recruiting
• Northwest Gastroenterologist
  Glenview, Illinois, United States Not yet recruiting
• University of Iowa
  Iowa City, Iowa, United States Not yet recruiting
• Johns Hopkins Bayview Medical Center
  Baltimore, Maryland, United States Not yet recruiting
• Digestive Disease Medicine of Central New York
  Utica, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.