Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
LactationInflammatory Bowel Disease
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
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 | 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 Italy
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 Italy