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A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Sponsor: Eli Lilly and Company
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
3 Weeks - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2026-06
Completion Date
2028-09
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
Mirikizumab
Administered SC
Locations (22)
Northwest Gastroenterologist
Glenview, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Digestive Disease Medicine of Central New York
Utica, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
GI Research
Columbia, Canada
Aarhus Universitetshospital, Aarhus Sygehus
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
Slagelse Hospital
Slagelse, Denmark
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
Frankfurt am Main, Germany
Klinikum Ernst von Bergmann
Potsdam, Germany
Rabin Medical Center - PPDS
HaMerkaz, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Israel
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
Lombardia, Italy
Ospedale di Rho - UOC Gastroenterologia
Rho, Italy
Ospedale Sandro Pertini
Roma, Italy
DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6
Radom, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Hospital Universitario La Paz
Madrid, Spain