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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 24, 2024

Primary Completion Date

October 1, 2025

Study Completion Date

February 6, 2026

Conditions
Inflammatory Bowel Disease
Interventions
PROCEDURE

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)

DRUG

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.

Trial Locations (3)

27514

University of North Carolina at Chapel Hill /ID# 263316, Chapel Hill

77024

UTHealth Women's Research Program - Memorial City /ID# 263939, Houston

91031

Shaare Zedek Medical Center /ID# 262738, Jerusalem

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY