drugset / Trial / NCT07654751
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Non-randomizedParallel-groupOpen-labelOther
Summary
The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications. This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.
Timeline
- Start
- 2026-08-07
- Primary completion
- 2027-08-31
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guselkumab | Monoclonal antibody | 100 mg | — |
| Subject | Guselkumab | Monoclonal antibody | 200 mg | — |