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

StatusRecruiting
PhasePhase 4
Started

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Record History

  1. Site details revised at 1 of 20 sitesv4
  2. Recruitment opened
    • Study sites: 22 to 20
    • Start date changed from estimate of Jun 2026 to Aug 5, 2026
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
366 trials monitored
See 16 trials at risk
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.
Trial Details
NCT Number NCT07612267
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Lactation, Inflammatory Bowel Disease
Related terms Breast Feeding, Inflammatory Bowel Diseases
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov