Guselkumab in Breast Milk for Lactating Women on Guselkumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This fully remote, post-marketing study collects breast milk samples from lactating women receiving guselkumab for psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn’s disease to measure drug levels. Participants complete consent, visits, and sample collection from home, with the goal of understanding drug exposure in breast milk. Eligibility requires established guselkumab maintenance therapy, being at least 5 weeks postpartum, and exclusive breastfeeding or minimal formula use. The study is led by Janssen with a collaborating site at the University of North Carolina, and focuses on real-world, passive data collection to inform safety for breastfeeding infants.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \[PsA\], UC and CD) as confirmed by medical records
* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1
* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study
* Must be at least 5 weeks postpartum on Day 1
* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study
* Must plan to continue breastfeeding throughout the duration of the study

Exclusion criteria

* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments
* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening
* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study
* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \[COVID-19\]) by local health authorities are allowed
* Has a positive urine pregnancy test on Day 1

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.