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NOT YET RECRUITING
NCT07654751
PHASE4

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

PROCEDURE

Breast Milk Sample Collection

Breast milk samples will be collected as per the schedule specified in protocol.

DRUG

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