Phase 4 Open-Label Study to Measure TREMFYA Levels in Breast Milk of Lactating Women Receiving Treatment

What This Trial Is About

This research aims to assess the amount of guselkumab, a medication used for approved conditions such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohns disease, present in the breast milk of lactating women who are receiving guselkumab as part of their regular medical care. The study is conducted remotely, allowing participants to complete all activities from home without visiting a study site. Participants will continue their scheduled guselkumab maintenance doses either every 4 weeks 200 mg or every 8 weeks 100 mg, depending on their treatment regimen and condition. For those on the 4-week regimen, four breast milk samples will be collected, while five samples will be collected for those on the 8-week regimen. The total study participation duration is approximately 8 weeks. During the study, participants will collect breast milk samples at specified times. Researchers will measure guselkumab concentrations at steady state in breast milk and estimate the daily infant dosage for both dosing schedules. Since the study is fully virtual, all consent, visits, and sample collections are done from home. The study will monitor participants over the 8-week period to understand medication levels in breast milk.

A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically