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NCT07612267PHASE4Recruiting

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

Eli Lilly and Company

Start Date

8/5/2026

Completion Date

9/1/2028

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 Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Mirikizumab

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Conditions

LactationInflammatory Bowel Disease

Locations

Northwest Gastroenterologist

Glenview, Illinois 60026-8000

United States

University of Iowa

Iowa City, Iowa 52242

United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland 21224-2735

United States

Digestive Disease Medicine of Central New York

Utica, New York 13502

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

GI Research

Columbia, V6G 2Z6

Canada

Aarhus Universitetshospital, Aarhus Sygehus

Aarhus N, 82000

Denmark

Slagelse Hospital

Slagelse, 4200

Denmark

Interdisziplinäres Crohn Colitis Centrum Rhein-Main

Frankfurt am Main, 60594

Germany

Klinikum Ernst von Bergmann

Potsdam, D-14467

Germany

Rabin Medical Center - PPDS

HaMerkaz,

Israel

Shaare Zedek Medical Center

Jerusalem, 9013102

Israel

Chaim Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, 6423906

Israel

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Lazio, 00136

Italy

Ospedale San Raffaele S.r.l. - PPDS

Lombardia, 20132

Italy

Ospedale di Rho - UOC Gastroenterologia

Rho, 20017

Italy

Ospedale Sandro Pertini

Roma, 00157

Italy

DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6

Radom, 26-610

Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501

Poland