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
Sex
FEMALE
Min age
3 Weeks
Max age
—
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
Primary outcome measure(s)
Concentration of Mirikizumab in Breast Milk — Predose up to 28 Days
Trial sites (20)
Facility
City
Region
Status
Northwest Gastroenterologist
Glenview
Illinois
Not Yet Recruiting
University of Iowa
Iowa City
Iowa
Not Yet Recruiting
Johns Hopkins Bayview Medical Center
Baltimore
Maryland
Not Yet Recruiting
Digestive Disease Medicine of Central New York
Utica
New York
Not Yet Recruiting
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Not Yet Recruiting
GI Research
Columbia
Canada
Not Yet Recruiting
Aarhus Universitetshospital, Aarhus Sygehus
Aarhus N
Denmark
Not Yet Recruiting
Slagelse Hospital
Slagelse
Denmark
Not Yet Recruiting
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
Frankfurt am Main
Germany
Not Yet Recruiting
Klinikum Ernst von Bergmann
Potsdam
Germany
Not Yet Recruiting
Rabin Medical Center - PPDS
HaMerkaz
Israel
Not Yet Recruiting
Shaare Zedek Medical Center
Jerusalem
Israel
Recruiting
Chaim Sheba Medical Center
Ramat Gan
Israel
Not Yet Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv
Israel
Recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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