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A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 21 days
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Illinois
Northwest Gastroenterologist
NOT_YET_RECRUITING
Glenview
Maryland
Johns Hopkins Bayview Medical Center
NOT_YET_RECRUITING
Baltimore
New York
Digestive Disease Medicine of Central New York
NOT_YET_RECRUITING
Utica
Ohio
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Other Locations
Canada
GI Research
NOT_YET_RECRUITING
Columbia
Denmark
Aarhus Universitetshospital, Aarhus Sygehus
NOT_YET_RECRUITING
Aarhus N
Slagelse Hospital
NOT_YET_RECRUITING
Slagelse
Germany
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
NOT_YET_RECRUITING
Frankfurt Am Main
Klinikum Ernst von Bergmann
NOT_YET_RECRUITING
Potsdam
Israel
Rabin Medical Center - PPDS
NOT_YET_RECRUITING
Hamerkaz
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Chaim Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center Ichilov - PPDS
RECRUITING
Tel Aviv
Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
NOT_YET_RECRUITING
Lazio
Ospedale San Raffaele S.r.l. - PPDS
NOT_YET_RECRUITING
Lombardia
Ospedale di Rho - UOC Gastroenterologia
NOT_YET_RECRUITING
Rho
Ospedale Sandro Pertini
NOT_YET_RECRUITING
Roma
Poland
DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6
NOT_YET_RECRUITING
Radom
WIP Warsaw IBD Point Profesor Kierkus
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2026-08-05
Estimated Completion Date:2028-09
Participants
Target number of participants:14
Treatments
Other: Mirikizumab
Participants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC).