A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
NCT07612267 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2026-05-28
Summary
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.
Conditions
- Lactation
- Inflammatory Bowel Disease
Interventions
- DRUG
-
Mirikizumab
Administered SC
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Weeks
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-09-30
- Completion
- 2028-09-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Denmark
- Germany
- Israel
- Italy
- Poland
- Spain
Study Locations
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