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
- Ages 3 Weeks and older
- Women only
Some of the main requirements, copied from the record:
- 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.
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
- About 14 participants are expected to take part.
- Start date: 2026-08-05.
- Main results expected around 2028-09 (estimate from the record).
- 20 study sites listed (2 marked recruiting) in Canada, Denmark, Germany, Israel and Italy and 2 more countries.
Main thing being measured
- Concentration of Mirikizumab in Breast Milk (Predose up to 28 Days)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Lactation; Inflammatory Bowel Disease |
| Lead sponsor | Eli Lilly and Company |
| Enrollment | 14 (estimated) |
| Start date | 2026-08-05 |
| Primary completion (est.) | 2028-09 |
| First posted | 2026-05-28 |
| Last updated | 2026-09-08 |
| 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 |
| ClinicalTrials.gov ID | NCT07612267 |
Interventions
- Mirikizumab (Drug)
Administered SC
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Gastroenterologist | Glenview, Illinois | United States | Not yet recruiting |
| University of Iowa | Iowa City, Iowa | United States | Not yet recruiting |
| Johns Hopkins Bayview Medical Center | Baltimore, Maryland | United States | Not yet recruiting |
| Digestive Disease Medicine of Central New York | Utica, New York | United States | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland, Ohio | United States | Not yet recruiting |
| GI Research | Columbia | Canada | Not yet recruiting |
| Aarhus Universitetshospital, Aarhus Sygehus | Aarhus N | Denmark | Not yet recruiting |
| Slagelse Hospital | Slagelse | Denmark | Not yet recruiting |
| Interdisziplinäres Crohn Colitis Centrum Rhein-Main | Frankfurt am Main | Germany | Not yet recruiting |
| Klinikum Ernst von Bergmann | Potsdam | Germany | Not yet recruiting |
| Rabin Medical Center - PPDS | HaMerkaz | Israel | Not yet recruiting |
| Shaare Zedek Medical Center | Jerusalem | Israel | Recruiting |
| Chaim Sheba Medical Center | Ramat Gan | Israel | Not yet recruiting |
| Tel Aviv Sourasky Medical Center Ichilov - PPDS | Tel Aviv | Israel | Recruiting |
| Fondazione Policlinico Universitario A Gemelli - Rome - PPDS | Lazio | Italy | Not yet recruiting |
| Ospedale San Raffaele S.r.l. - PPDS | Lombardia | Italy | Not yet recruiting |
| Ospedale di Rho - UOC Gastroenterologia | Rho | Italy | Not yet recruiting |
| Ospedale Sandro Pertini | Roma | Italy | Not yet recruiting |
| DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6 | Radom | Poland | Not yet recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Not 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.