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A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Sponsor: Janssen Research & Development, LLC
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.
Official title: CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-06-15
Completion Date
2027-08-31
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
Breast Milk Sample Collection
Breast milk samples will be collected as per the schedule specified in protocol.
Guselkumab
Guselkumab as prescribed by the participant's treating physician and obtained by the participant outside of the study per the treating physician's practice will be used.
Locations (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States