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

September 4, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Canada
      • Columbia, Canada, V6G 2Z6
        • Not yet recruiting
        • GI Research
        • Principal Investigator:
          • Yvette Leung
  • Denmark
      • Aarhus N, Denmark, 82000
        • Not yet recruiting
        • Aarhus Universitetshospital, Aarhus Sygehus
        • Principal Investigator:
          • Mette Juelsgaard
      • Slagelse, Denmark, 4200
        • Not yet recruiting
        • Slagelse Hospital
        • Principal Investigator:
          • Natalia Pedersen
  • Germany
      • Frankfurt am Main, Germany, 60594
        • Not yet recruiting
        • Interdisziplinäres Crohn Colitis Centrum Rhein-Main
        • Principal Investigator:
          • Juergen Stein
      • Potsdam, Germany, D-14467
        • Not yet recruiting
        • Klinikum Ernst von Bergmann
        • Principal Investigator:
          • Daniel Baumgart
  • Israel
      • HaMerkaz, Israel
        • Not yet recruiting
        • Rabin Medical Center - PPDS
        • Principal Investigator:
          • Irit Avni-Biron
      • Jerusalem, Israel, 9013102
        • Recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Ariella Shitrit
      • Ramat Gan, Israel, 52621
        • Not yet recruiting
        • Chaim Sheba Medical Center
        • Principal Investigator:
          • Bella Ungar
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center Ichilov - PPDS
        • Principal Investigator:
          • Nathaniel Cohen
  • Italy
      • Lazio, Italy, 00136
        • Not yet recruiting
        • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
        • Principal Investigator:
          • Antonio Gasbarrini
      • Lombardia, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
        • Principal Investigator:
          • Silvio Danese
      • Rho, Italy, 20017
        • Not yet recruiting
        • Ospedale di Rho - UOC Gastroenterologia
        • Principal Investigator:
          • Simone Saibeni
      • Roma, Italy, 00157
        • Not yet recruiting
        • Ospedale Sandro Pertini
        • Principal Investigator:
          • Roberta Pica
  • Poland
      • Radom, Poland, 26-610
        • Not yet recruiting
        • DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6
        • Principal Investigator:
          • Romanowski Janusz
      • Warsaw, Poland, 04-501
        • Not yet recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Jaroslaw Kierkus
  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026-8000
        • Not yet recruiting
        • Northwest Gastroenterologist
        • Principal Investigator:
          • Nina Merel
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Principal Investigator:
          • Steven Polyak
    • Maryland
      • Baltimore, Maryland, United States, 21224-2735
        • Not yet recruiting
        • Johns Hopkins Bayview Medical Center
        • Principal Investigator:
          • Muniz Pedrogo David
    • New York
      • Utica, New York, United States, 13502
        • Not yet recruiting
        • Digestive Disease Medicine of Central New York
        • Principal Investigator:
          • Harvey Allen
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Angelina Gangestad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mirikizumab
Participants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC).
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of Mirikizumab in Breast Milk
Time Frame: Predose up to 28 Days
Predose up to 28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk
Time Frame: Predose up to 28 Days
Predose up to 28 Days
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk
Time Frame: Predose up to 28 Days
Predose up to 28 Days
Breastfed Infant Safety as Assessed through Measurement of Infant Weight
Time Frame: Predose up to 28 Days
Predose up to 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18780
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • I6T-MC-AMCA (Other Identifier: Eli Lilly and Company)
  • 2025-522362-78-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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