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.
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 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
Single group
Mirikizumab
DrugAdministered SC
Concentration of Mirikizumab in Breast Milk
Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk
Breastfed Infant Safety as Assessed through Measurement of Infant Weight
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