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A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Sponsor: AbbVie
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.
Official title: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-04-24
Completion Date
2026-02-05
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
Breast Milk Sampling
Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of commercial risankizumab at pre-dose and 1 hour after dosing on Day 1, on Days 4 (± 1), 8 (± 2), 15 (± 3), 29 (± 3), and pre-dose on Day 57 (± 3)
Risankizumab
Participants will have already been taking commercial risankizumab and will continue on commercial risankizumab. Participants will not be provided risankizumab from the study. Participants must have received at least 2 doses of 360 mg of risankizumab SC every 8 weeks postpartum prior to start of participation in this study.
Locations (3)
University of North Carolina at Chapel Hill /ID# 263316
Chapel Hill, North Carolina, United States
UTHealth Women's Research Program - Memorial City /ID# 263939
Houston, Texas, United States
Shaare Zedek Medical Center /ID# 262738
Jerusalem, Jerusalem, Israel