A study to measure mirikizumab levels in breast milk of lactating participants receiving mirikizumab therapeutically for an approved indication

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Eli Lilly and Company

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacokinetic

To assess the concentration of mirikizumab in breast milk of lactating participants receiving maintenance SC mirikizumab for an approved indication.

Secondary objectives 2

1. To evaluate mirikizumab PK parameters in breast milk of lactating participants receiving maintenance SC mirikizumab for an approved indication.
2. To assess the effects on the breastfed infant

Conditions and MedDRA coding

severely active ulcerative colitis (US) and CD (Crohn’s disease)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. 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.
2. 2. Multiple births may be allowed following discussion with the medical monitor.
3. 3. Lactation history is well established, with the mother exclusively breastfeeding her infant (not to exceed more than 1 bottle of formula per day).
4. 4. Mother participant is receiving mirikizumab therapeutically for an approved diagnosis in the participant’s location.
5. 5. 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.
6. 6. 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.
7. 7. 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.
8. 8. Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula
9. 9. 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)
10. 10. The decision to treat with mirikizumab or to breast feed is made independently from and prior to the mother participant consenting for the study.
11. 11. Mother participant agrees to use only the emollient or nipple cream recommended by the HCP for use during the sampling period.

Exclusion criteria 16

1. 1. Have hypersensitivity to mirikizumab or to any of the excipients listed in the label.
2. 2. 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
3. 3. Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered.
4. 4. Have a history of inadequate lactation, for multiparous mother participants who have previously breastfed.
5. 5. 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.
6. 6. 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.
7. 7. Had a clinically important infection, which is now resolved, such as pneumonia or pyelonephritis, within 14 days prior to enrollment.
8. 8. 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.
9. 9. 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.
10. 10. 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.
11. 11. Has a history of or current alcohol use disorder or substance use disorder.
12. 12. Has clinically important liver disease such as advanced fibrosis or cirrhosis.
13. 13. Is unable to participate in all the study visits or comply with study procedures.
14. 14. 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.
15. 15. In the opinion of the HCP or sponsor, are unsuitable for inclusion in the study
16. 16. Are Eli Lilly and Company (Lilly) employees or are employees of a third-party organization involved with the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Concentration of mirikizumab in breast milk predose on Day 0, as well as each day that breast milk collection is indicated in the SoA (Section 1.3).

Secondary endpoints 2

1. AUC(0-τ), Cavg, Ctrough, Cmax, and tmax
2. Infant weight and caregiver- or HCP-reported adverse events.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 9

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 7

Locations

5 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications