Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
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IBD (general)Recruiting

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

Phase 4 · Testing Mirikizumab · 20 sites · Eli Lilly and Company

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Mirikizumab (a drug). Condition(s) listed: Lactation and Inflammatory Bowel Disease.

It is open-label: participants know what they are receiving.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Some of the main requirements, copied from the record:

Plus 4 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 4
Study typeInterventional
ConditionsLactation; Inflammatory Bowel Disease
Lead sponsorEli Lilly and Company
Enrollment14 (estimated)
Start date2026-08-05
Primary completion (est.)2028-09
First posted2026-05-28
Last updated2026-09-08
Official titleA 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
ClinicalTrials.gov IDNCT07612267

Interventions

Full eligibility criteria (from the record)
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

Locations (20)

SiteCityCountrySite status
Northwest GastroenterologistGlenview, IllinoisUnited StatesNot yet recruiting
University of IowaIowa City, IowaUnited StatesNot yet recruiting
Johns Hopkins Bayview Medical CenterBaltimore, MarylandUnited StatesNot yet recruiting
Digestive Disease Medicine of Central New YorkUtica, New YorkUnited StatesNot yet recruiting
University Hospitals Cleveland Medical CenterCleveland, OhioUnited StatesNot yet recruiting
GI ResearchColumbiaCanadaNot yet recruiting
Aarhus Universitetshospital, Aarhus SygehusAarhus NDenmarkNot yet recruiting
Slagelse HospitalSlagelseDenmarkNot yet recruiting
Interdisziplinäres Crohn Colitis Centrum Rhein-MainFrankfurt am MainGermanyNot yet recruiting
Klinikum Ernst von BergmannPotsdamGermanyNot yet recruiting
Rabin Medical Center - PPDSHaMerkazIsraelNot yet recruiting
Shaare Zedek Medical CenterJerusalemIsraelRecruiting
Chaim Sheba Medical CenterRamat GanIsraelNot yet recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDSTel AvivIsraelRecruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDSLazioItalyNot yet recruiting
Ospedale San Raffaele S.r.l. - PPDSLombardiaItalyNot yet recruiting
Ospedale di Rho - UOC GastroenterologiaRhoItalyNot yet recruiting
Ospedale Sandro PertiniRomaItalyNot yet recruiting
DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6RadomPolandNot yet recruiting
WIP Warsaw IBD Point Profesor KierkusWarsawPolandNot yet recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.