RecruitingPhase 4NCT07612267

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

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

Sponsor

Eli Lilly and Company

Enrollment

14 participants

Start Date

Aug 5, 2026

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Disease Lactation

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

Sex: FEMALEMin Age: 3 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mirikizumab for people with inflammatory bowel disease and lactation. The study is currently recruiting participants at 20 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirikizumab

Administered SC

Locations(20)

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

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

View Full Details on ClinicalTrials.gov

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NCT07612267

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