Measuring mirikizumab in breast milk of nursing mothers with ulcerative colitis or Crohn's disease

Who can take part

• Mothers who are at least 18 years of age at the time of signing the informed consent and their infants, who are at least 36 weeks gestational age at birth, and at least 3 weeks old by Study Day 0. Note: In the opinion of the HCP, there are no infant or maternal issues that would preclude the mother participant or the infant from participation
• The decision to treat with mirikizumab or to breast feed is made independently from and prior to the mother participant consenting for the study
• Mother participant agrees to use only the emollient or nipple cream recommended by the HCP for use during the sampling period
• Multiple births may be allowed following discussion with the medical monitor
• Lactation history is well established, with the mother exclusively breastfeeding her infant (not to exceed more than 1 bottle of formula per day)
• Mother participant is receiving mirikizumab therapeutically for an approved diagnosis in the participant’s location
• Mother participant is assigned female at birth. Contraceptive use by mother participant should be consistent with local regulations and clinical practice regarding the methods of contraception for those participating in clinical studies. For contraception-related definitions see Section 10.4 of the protocol
• Are capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
• Are not pregnant as confirmed by pregnancy testing at the beginning of the study and agree not to become pregnant for the duration of the study
• Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula
• Mother participant must be on established mirikizumab maintenance therapy (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)

Who cannot take part

• Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing
• 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 a history of inadequate lactation, for multiparous mother participants who have previously breastfed
• Had a clinically important infection, which is now resolved, such as pneumonia or pyelonephritis, within 14 days prior to enrollment
• 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
• Are currently enrolled in or plan to enroll in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have hypersensitivity to mirikizumab or to any of the excipients listed in the label
• Has a history of or current alcohol use disorder or substance use disorder
• Has clinically important liver disease such as advanced fibrosis or cirrhosis
• 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
• The mother participant currently has a clinically important active infection such as but not limited to human immunodeficiency virus, hepatitis B, hepatitis C, active tuberculosis, or untreated latent tuberculosis
• Is unable to participate in all the study visits or comply with study procedures
• Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
• In the opinion of the HCP or sponsor, are unsuitable for inclusion in the study
• Are Eli Lilly and Company (Lilly) employees or are employees of a third-party organization involved with the study