NCT07654751
A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Not Yet Recruiting
PHASE4Ages 18+InterventionalJanssen Research & Development, LLC
~10 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Breast Milk Sample CollectionGuselkumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)
Measured over Up to Day 29
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)Up to Day 29
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q4W maintenance regimen will be reported.
- Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen)Up to Day 57
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q8W maintenance regimen will be reported.
- Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance RegimenUp to Day 29
The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported.
- Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance RegimenUp to Day 57
The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported.