Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06346288
PHASE4

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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

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.

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