A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease

Study Identifier
M24-144
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Inflammatory Bowel Disease (IBD)
  • Study Drug
  • Risankizumab
  • Phase
    Phase 4
    Sex
    Female
    Age
    18+ years

    Protocol Summary

    Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD

    Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.

    Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.

    Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.

    Study Locations

    Location
    Status
    Location
    University of North Carolina at Chapel Hill /ID# 263316
    Chapel Hill, North Carolina, United States, 27514
    Status
    Not applicable
    Location
    UTHealth Women's Research Program - Memorial City /ID# 263939
    Houston, Texas, United States, 77024
    Status
    Not applicable
    Location
    Shaare Zedek Medical Center /ID# 262738
    Jerusalem, Jerusalem, Israel, 91031
    Status
    Not applicable