NCT06346288

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will only include lactating women who are receiving treatment with risankizumab for IBD in accordance with their treating physician, although this study is non-interventional regarding treatment with risankizumab, it is considered interventional due to the collection of breast milk from the lactating mothers.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-24
• Primary completion: 2025-08-06
• Completion: 2026-02-05
• First posted: 2024-04-04
• Last updated: 2026-02-27

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study