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First received: March 22, 2024

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Inflammatory Bowel Disease

Study Type: INTERVENTIONAL


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 Therapeuticall

Brief 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 IBDRisankizumab 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…

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