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
3 other identifiers
interventional
14
8 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2026
Typical duration for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
May 28, 2026
May 1, 2026
2.3 years
May 21, 2026
May 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Concentration of Mirikizumab in Breast Milk
Predose up to 28 Days
Secondary Outcomes (3)
Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk
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
Predose up to 28 Days
Breastfed Infant Safety as Assessed through Measurement of Infant Weight
Predose up to 28 Days
Study Arms (1)
Mirikizumab
OTHERParticipants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Rigshospitalet
Copenhagen, 2100, 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
Hospital Universitario La Paz
Madrid, 28046, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2026
First Posted
May 28, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.