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NOT YET RECRUITING
NCT07612267
PHASE4

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Interventions

DRUG

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