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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

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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 Aug 2025

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At a glance

  • Drugs Risankizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors AbbVie

Most Recent Events

  • 17 Aug 2025 Status changed from recruiting to active, no longer recruiting.
  • 11 Aug 2025 Planned End Date changed from 27 Dec 2025 to 6 Feb 2026.
  • 11 Aug 2025 Planned primary completion date changed from 25 Aug 2025 to 1 Oct 2025.

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