Cure8 trial brief
People with IBD who are breastfeeding and are taking guselkumab may want data on how much of the drug gets into breast milk and the estimated infant exposure. This study aims to provide those measurements for the Q4W and Q8W maintenance regimens.
Lactating adult patients with Crohn’s disease or ulcerative colitis who are receiving guselkumab, breastfeeding parents and caregivers, gastroenterologists and dermatologists prescribing guselkumab, and researchers studying drug transfer into breast milk.
This trial is designed to quantify how much guselkumab appears in breast milk when breastfeeding people are on maintenance dosing (either every 4 or 8 weeks). Participants continue to receive the drug as prescribed by their treating clinician; the study itself collects breast milk samples and estimates infant exposure.
Eligibility is limited to adults (≥18 years), at least 5 weeks postpartum, with well-established lactation who are exclusively or nearly exclusively breastfeeding and who have already received at least two maintenance doses of guselkumab. The planned enrollment is small (about 10 participants) and the study duration per participant is 8 weeks.
The study is a post-marketing, Phase 4, sample-collection study rather than a randomized efficacy trial; its goal is pharmacokinetic measurement in breast milk rather than assessing clinical outcomes for mother or infant.
This is a Phase 4, post-marketing pharmacokinetic study with a small planned enrollment and short follow-up focused on breast milk concentrations and estimated infant dose. It does not appear to be designed to assess infant clinical outcomes or safety.
The record is a trial registration (not a peer-reviewed report); results would need to be posted or published to inform practice.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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