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

NCT07612267

RecruitingPhase 4

Sponsor: Eli Lilly and Company

Conditions: Lactation, Inflammatory Bowel Disease

Interventions: Mirikizumab

Countries: United States, Canada, Denmark, Germany, Israel, Italy, Poland

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.

Eligibility overview

Sex: FEMALE

Age: 3 Weeks to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (20)

Glenview, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Utica, New York, United States
Cleveland, Ohio, United States
Columbia, Canada
Aarhus N, Denmark
Slagelse, Denmark
Frankfurt am Main, Germany
Potsdam, Germany
HaMerkaz, Israel
Jerusalem, Israel
Ramat Gan, Israel
Tel Aviv, Israel
Lazio, Italy
Lombardia, Italy
Rho, Italy
Roma, Italy
Radom, Poland
Warsaw, Poland