PsoriasisPhase 4NCT07654751
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
A Phase 4 study testing Breast Milk Sample Collection and Guselkumab in people with Psoriasis and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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. This is a fully remote (virtual) study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psoriasis, Colitis, Ulcerative, Crohn Disease
- What is being tested?
- Breast Milk Sample Collection and Guselkumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to 31 Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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
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.
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.
- Conditions
- Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
- Being tested
- Breast Milk Sample Collection, Guselkumab
- Medical subject headings
- Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Milk Sample CollectionProcedure or surgery
Breast milk samples will be collected as per the schedule specified in protocol.
GuselkumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen | Experimental | 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. Receives: Procedure: Breast Milk Sample Collection; Drug: Guselkumab |
| Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen | Experimental | 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. Receives: Procedure: Breast Milk Sample Collection; Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q4W maintenance regimen will be reported.
Measured: Up to Day 29
Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen)
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q8W maintenance regimen will be reported.
Measured: Up to Day 57
Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported.
Measured: Up to Day 29
Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported.
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start7 Aug 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654751
- Sponsor's protocol ID
- CNTO1959ISD4001
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.