Evaluation of Mirikizumab Concentrations in Breast Milk Among Lactating Participants Receiving Subcutaneous Mirikizumab for Ulcerative Colitis or Crohn's Disease
- Trial ID
- 2025-522362-78-00
- Protocol
- I6T-MC-AMCA
- Sponsor
- Eli Lilly & Co.
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to assess the concentration of mirikizumab in breast milk among lactating participants receiving maintenance subcutaneous injection for an approved indication. This evaluation is clinically relevant to understanding the transfer of the therapeutic agent during lactation. Secondary objectives include:
- Evaluation of pharmacokinetic parameters of mirikizumab in breast milk.
- Assessment of effects on the breastfed infant.
Participants
This study involves 11 participants assigned female at birth who are currently receiving maintenance therapy for ulcerative colitis or Crohn's disease. The study population consists of lactating individuals, aged 18 years or older, who are exclusively breastfeeding their infants, with a limitation of no more than one bottle of formula per day. Included infants must have a gestational age of at least 36 weeks at birth and be at least 3 weeks of age by the start of the study. Participants must be on an established regimen of subcutaneous mirikizumab, having received at least two doses prior to the study period. Requirements for participation include the absence of pregnancy and the use of only healthcare provider-recommended emollient or nipple cream during the sampling period.
Plans and Procedures
This phase 6 clinical study is designed to assess the concentration of mirikizumab in breast milk among lactating participants who are receiving subcutaneous injection maintenance therapy for an approved indication, such as ulcerative colitis or Crohn’s disease. The primary objective is to measure the concentration of the drug in breast milk predose on Day 0 and on subsequent days as indicated by the schedule of activities. Secondary endpoints include pharmacokinetic parameters such as AUC, Cmax, and Ctrough, as well as infant weight and reported adverse events. The study involves participants who have an established lactation history and are receiving maintenance doses of the medication every four weeks. The estimated duration of the study, including recruitment, spans from March 2026 to August 2027.
Treatment
The experimental treatment consists of mirikizumab, provided as a solution for injection. This medication is administered via subcutaneous injection using various delivery devices, including pre-filled syringes and pre-filled pens. Available concentrations include 100 mg and combinations of 100 mg plus 200 mg.
Efficacy
The primary efficacy endpoint is the concentration of mirikizumab in breast milk, measured predose on Day 0 and on each day specified for collection. Secondary endpoints include pharmacokinetic parameters, specifically AUC(0-τ), Cavg, Ctrough, Cmax, and tmax. Additional secondary assessments involve monitoring infant weight and adverse events reported by caregivers or healthcare professionals.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Mothers who are at least 18 years of age at the time of signing the informed consent and their infants, who are at least 36 weeks gestational age at birth, and at least 3 weeks old by Study Day 0. Note: In the opinion of the HCP, there are no infant or maternal issues that would preclude the mother participant or the infant from participation.
- Multiple births may be allowed following discussion with the medical monitor.
- Lactation history is well established, with the mother exclusively breastfeeding her infant (not to exceed more than 1 bottle of formula per day).
- Mother participant is receiving mirikizumab therapeutically for an approved diagnosis in the participant’s location.
- Mother participant is assigned female at birth. Contraceptive use by mother participant should be consistent with local regulations and clinical practice regarding the methods of contraception for those participating in clinical studies. For contraception-related definitions see Section 10.4 of the protocol.
- Are capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Are not pregnant as confirmed by pregnancy testing at the beginning of the study and agree not to become pregnant for the duration of the study.
- Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula
- Mother participant must be on established mirikizumab maintenance therapy (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)
- The decision to treat with mirikizumab or to breast feed is made independently from and prior to the mother participant consenting for the study.
- Mother participant agrees to use only the emollient or nipple cream recommended by the HCP for use during the sampling period.
Exclusion Criteria
- Have hypersensitivity to mirikizumab or to any of the excipients listed in the label.
- 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 inadequate lactation, for multiparous mother participants who have previously breastfed.
- 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.
- The mother participant currently has a clinically important active infection such as but not limited to human immunodeficiency virus, hepatitis B, hepatitis C, active tuberculosis, or untreated latent tuberculosis.
- Had a clinically important infection, which is now resolved, such as pneumonia or pyelonephritis, within 14 days prior to enrollment.
- 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.
- Are currently enrolled in or plan to enroll in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.
- Has a history of or current alcohol use disorder or substance use disorder.
- Has clinically important liver disease such as advanced fibrosis or cirrhosis.
- Is unable to participate in all the study visits or comply with study procedures.
- Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- In the opinion of the HCP or sponsor, are unsuitable for inclusion in the study
- Are Eli Lilly and Company (Lilly) employees or are employees of a third-party organization involved with the study.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Not Yet Recruiting | 01 Mar 2026 | 2 |
 Germany | Recruiting | 01 Mar 2026 | 3 |
 Italy | Recruiting | 01 Mar 2026 | 7 |
 Poland | Recruiting | 01 Mar 2026 | 2 |
 Spain | Not Recruiting | 01 Mar 2026 | 2 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Omvoh 100 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 0 | 1 | PRD10448235 |
Omvoh 100 mg + 200 mg solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS INJECTION | 0 | 1 | PRD12100410 |
Omvoh 100 mg + 200 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 0 | 1 | PRD12100333 |
Omvoh 100 mg solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS INJECTION | 0 | 1 | PRD10448237 |
Omvoh 100 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 0 | 1 | PRD10456005 |
Omvoh 100 mg solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS INJECTION | 0 | 1 | PRD10448236 |
Omvoh 100 mg + 200 mg solution for injection in pre-filled syringe | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 0 | 1 | PRD12100332 |
Omvoh 100 mg + 200 mg solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS INJECTION | 0 | 1 | PRD12100411 |
Omvoh 100 mg solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | SUBCUTANEOUS INJECTION | 0 | 1 | PRD10448238 |