Inflammatory Bowel Disease, Lactation
Conditions
Brief summary
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.
Interventions
DRUGMirikizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
3 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of Mirikizumab in Breast Milk | Predose up to 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk | Predose up to 28 Days |
| Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk | Predose up to 28 Days |
| Breastfed Infant Safety as Assessed through Measurement of Infant Weight | Predose up to 28 Days |
Countries
Canada, Denmark, Germany, Israel, Italy, Poland, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed