A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Completed · Phase 4 · NCT06346288
Conditions: Inflammatory Bowel Disease
At a glance
- Research payments reported, 2025
- $26,304
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 10
About the trial
- Sponsor
- AbbVie
- Tested
- Breast Milk Sampling (procedure), Risankizumab (drug)
- Dates
- Started 2024-04-24; completion 2026-02-05
- Results posted
- Not yet
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…
From ClinicalTrials.gov, last updated 2026-04-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $26,304 in research payments for this study in 2025 (13 payments).
Products named: Skyrizi
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Millie D. Long, MD Internal Medicine · Chapel Hill, NC
- Sandra M. Hurtado, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of North Carolina $20,500
- University of Texas Health Science $5,804
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.