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Taking people in United StatesPhase 4

Measuring guselkumab in breast milk of nursing mothers treated for psoriasis or bowel disease

Measures how much guselkumab appears in breast milk of women already receiving it.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Chapel Hill, United StatesSee the site
Trial code
Registry title
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Status
Recruiting
Phase
Phase 4
People taking part
10 people, planned
Started
7 Aug 2026
Expected to end
31 Aug 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Breast Milk Sample Collection
  • Guselkumab
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for breastfeeding women who already take guselkumab (TREMFYA) for psoriasis, psoriatic arthritis, ulcerative colitis or Crohn's disease. It measures how much of the drug is in their breast milk.

Age
18 years or older
Sex
Women only
Disease stage
An active diagnosis of psoriasis, psoriatic arthritis, ulcerative colitis or Crohn's disease, confirmed by medical records. Medically stable.
Earlier treatment
Must be on steady guselkumab treatment, with at least 2 subcutaneous maintenance doses before Day 1.

Main reasons for not taking part

  • Any illness that could confound the study results or limit the study assessments
  • Drug or alcohol abuse within 1 year before screening
  • Investigational drug or device used within 1 month before enrolling
  • Live, attenuated vaccine within 12 weeks before guselkumab
  • Positive urine pregnancy test on Day 1

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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
  • Has a positive urine pregnancy test on Day 1

Where in United States

  • University of North Carolina at Chapel HillChapel Hill, United StatesTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.

The 2 groups in the trial

  • Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) RegimenTreatment being tested

    Participants who have been on guselkumab maintenance therapy and received at least 2 maintenance doses of guselkumab Q4W for any of the approved indications: ulcerative colitis (UC) or Crohn's Disease (CD), will be enrolled. On Day 1 of the study, participants will receive their scheduled guselkumab maintenance dose of 200 mg every 4 weeks. A total of 4 breast milk samples will be collected. The total study duration per participant will be 8 weeks.

    Treatment: Breast Milk Sample Collection and Guselkumab

  • Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) RegimenTreatment being tested

    Participants who have been on guselkumab maintenance therapy and received at least 2 maintenance doses of guselkumab Q8W regimen for any of the approved indications: psoriasis, psoriatic arthritis (pSA) or UC or CD, will be enrolled. On Day 1 of the study, the participants will receive their scheduled guselkumab maintenance dose of 100 mg every 8 weeks. A total of 5 breast milk samples will be collected. The total study duration per participant will be 8 weeks.

    Treatment: Breast Milk Sample Collection and Guselkumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Measuring guselkumab in breast milk of nursing mothers treated for psoriasis or bowel diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026