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Not yet recruiting NCT07612267

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

Phase IV Interventional Lactation Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirikizumab.
Who it may be relevant to
Registry conditions: Lactation, Inflammatory Bowel Disease. Basic parameters: from 3 Weeks · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Denmark, Germany, Israel +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication

Overview

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.

Interventions

  • Drug Mirikizumab
    Administered SC

Primary outcome measures

  • Concentration of Mirikizumab in Breast Milk [Time frame: Predose up to 28 Days]
Secondary outcome measures (3)
  • Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk [Time frame: Predose up to 28 Days]
  • Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk [Time frame: Predose up to 28 Days]
  • Breastfed Infant Safety as Assessed through Measurement of Infant Weight [Time frame: Predose up to 28 Days]

Eligibility criteria

Inclusion criteria

Study Participants:

  • Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0
  • Multiple births may be allowed following discussion with the medical monitor.

Note: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation

  • Lactation history is well established, with the mother exclusively breastfeeding her infant
  • Mother participant is receiving mirikizumab therapeutically for an approved diagnosis (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)
  • Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula

Exclusion criteria

  • Have a history of inadequate lactation, for multiparous participants who have previously breastfed
  • 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
  • Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered
  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 5 centers
  • Northwest Gastroenterologist — Glenview
  • University of Iowa — Iowa City
  • Johns Hopkins Bayview Medical Center — Baltimore
  • Digestive Disease Medicine of Central New York — Utica
  • University Hospitals Cleveland Medical Center — Cleveland
Israel · 4 centers
  • Rabin Medical Center - PPDS — HaMerkaz
  • Shaare Zedek Medical Center — Jerusalem
  • Chaim Sheba Medical Center — Ramat Gan
  • Tel Aviv Sourasky Medical Center Ichilov - PPDS — Tel Aviv
Italy · 4 centers
  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS — Lazio
  • Ospedale San Raffaele S.r.l. - PPDS — Lombardia
  • Ospedale di Rho - UOC Gastroenterologia — Rho
  • Ospedale Sandro Pertini — Roma
Denmark · 3 centers
  • Aarhus Universitetshospital, Aarhus Sygehus — Aarhus N
  • Rigshospitalet — Copenhagen
  • Slagelse Hospital — Slagelse
Germany · 2 centers
  • Interdisziplinäres Crohn Colitis Centrum Rhein-Main — Frankfurt am Main
  • Klinikum Ernst von Bergmann — Potsdam
Poland · 2 centers
  • DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6 — Radom
  • WIP Warsaw IBD Point Profesor Kierkus — Warsaw
Canada · 1 center
  • GI Research — Columbia
Spain · 1 center
  • Hospital Universitario La Paz — Madrid

Identifiers

NCT: NCT07612267 · 18780 · I6T-MC-AMCA · 2025-522362-78-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗