RecruitingPhase 4NCT07654751

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

10 participants

Start Date

Aug 7, 2026

Study Type

INTERVENTIONAL

Conditions

Crohn Disease Psoriasis Colitis Ulcerative Arthritis, Psoriatic

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Breast Milk Sample Collection and a drug called Guselkumab for people with arthritis, psoriatic, colitis ulcerative, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBreast Milk Sample Collection

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

DRUGGuselkumab

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

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NCT07654751

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