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

Part of paid clinical trials in Glenview, Illinois.

Sponsor
Eli Lilly and Company
Study ID
NCT07612267
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Inflammatory Bowel Disease
  • Lactation

Eligibility Criteria

Sex
FEMALE
Age
3 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Mirikizumab
    Participants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC).

Primary Outcome Measure

Concentration of Mirikizumab in Breast Milk [ Time Frame: Predose up to 28 Days ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Northwest GastroenterologistGlenviewIllinois60026-8000
Nina Merel (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Steven Polyak (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-2735
Muniz Pedrogo David (PRINCIPAL_INVESTIGATOR)
Digestive Disease Medicine of Central New YorkUticaNew York13502
Harvey Allen (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Angelina Gangestad (PRINCIPAL_INVESTIGATOR)

Find similar trials in Glenview, IL

By research site
Northwest Gastroenterologist· Glenview, ILUniversity of Iowa· Iowa City, IAJohns Hopkins Bayview Medical Center· Baltimore, MDDigestive Disease Medicine of Central New York· Utica, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OH

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