mirikizumab for Ulcerative colitis|Crohn's disease

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 11. Mother participant agrees to use only the emollient or nipple cream recommended by the HCP for use during the sampling period."}
• {"criterion_text":"- 2. Multiple births may be allowed following discussion with the medical monitor."}
• {"criterion_text":"- 3. Lactation history is well established, with the mother exclusively breastfeeding her infant (not to exceed more than 1 bottle of formula per day)."}
• {"criterion_text":"- 4. Mother participant is receiving mirikizumab therapeutically for an approved diagnosis in the participant’s location."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 8. Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula"}
• {"criterion_text":"- 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)"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measure mirikizumab concentration in breast milk predose on Day 0 and on each day indicated in the Schedule of Activities (SoA, Section 1.3); main objective is to assess mirikizumab concentration in breast milk of lactating participants receiving maintenance SC mirikizumab for an approved indication."}

Secondary endpoints

• {"endpoint_text":"- AUC(0-τ), Cavg, Ctrough, Cmax, and tmax","definition_or_measurement_approach":"Pharmacokinetic parameters in breast milk (AUC(0-τ), Cavg, Ctrough, Cmax, tmax) to be calculated from mirikizumab concentration-time data."}
• {"endpoint_text":"- Infant weight and caregiver- or HCP-reported adverse events.","definition_or_measurement_approach":"Monitor infant weight and record adverse events reported by caregiver or healthcare professional."}

Italy

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

33

Number Of Sites

4

Number Of Participants

7

Germany

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

27

Number Of Sites

3

Number Of Participants

3

Poland

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

14

Number Of Sites

2

Number Of Participants

2

Denmark

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

32

Number Of Sites

1

Number Of Participants

2

Spain

Earliest CTIS Part Ii Submission Date

13-02-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

76

Number Of Sites

1

Number Of Participants

2

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

codes: [4]

Name

PPD Development LP

Responsibilities

Start-Up Management, Digital Implementation, Home Trial Services; Lab supplies management; Home Trial service (various addresses)

Name

Icon Development Solutions LLC

Responsibilities

codes: [4]

Third parties

• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: [1,10,11,12,13,15,2,5,6,7,9]; value: Start-Up Management, Digital Implementation, Home Trial Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"code: [15]; value: ePRO service","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"PPD Development LP (Austin address)","duties_or_roles":"code: [15]; value: Lab supplies management","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP (Wilmington address)","duties_or_roles":"code: [15]; value: Home Trial service","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code: [15]; value: Patient Reimbursement services","organisation_type":"Hospital/Clinic/Other health care facility"}