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Clinical Trials in Denmark / NCT07612267
Recruiting Phase 4

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

NCT07612267 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2026-08-05
Last updated
2026-09-08

Condition(s) studied

LactationInflammatory Bowel Disease

Investigational drug(s) / intervention(s)

Mirikizumab →

Mirikizumab: Administered SC

Study 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.

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)

Trial sites (20)

FacilityCityRegionStatus
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 Lazio Italy Not Yet Recruiting
Ospedale San Raffaele S.r.l. - PPDS Lombardia Italy Not Yet Recruiting
Ospedale di Rho - UOC Gastroenterologia Rho Italy Not Yet Recruiting
Ospedale Sandro Pertini Roma Italy Not Yet Recruiting
DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6 Radom Poland Not Yet Recruiting
WIP Warsaw IBD Point Profesor Kierkus Warsaw Poland Not Yet Recruiting

On this site

📄 Omvoh (mirikizumab) drug profile →

More Eli Lilly and Company trials in Denmark

Other trials for the same condition

Official registry record

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.

View NCT07612267 on ClinicalTrials.gov ↗ ← All trials in Denmark