Crohn'sUCRecruiting
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Phase 4 · Testing Breast Milk Sample Collection and Guselkumab · 1 site · Janssen Research & Development, LLC
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Breast Milk Sample Collection (a procedure) and Guselkumab (a drug). Condition(s) listed: Psoriasis, Colitis, Ulcerative and Crohn Disease.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Women only
Some of the main requirements, copied from the record:
- 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…
- 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
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- The study has 2 groups.
- Start date: 2026-08-07.
- Main results expected around 2027-08-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen (listed as: experimental group)
- Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen (listed as: experimental group)
Main thing being measured
- Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) (Up to Day 29)
- Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen) (Up to Day 57)
- Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen (Up to Day 29)
In the researchers’ words
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…
Words you might see
- Maintenance: longer-term treatment aimed at keeping the disease under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Psoriasis; Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic |
| Lead sponsor | Janssen Research & Development, LLC |
| Enrollment | 10 (estimated) |
| Start date | 2026-08-07 |
| Primary completion (est.) | 2027-08-31 |
| First posted | 2026-06-17 |
| Last updated | 2026-10-05 |
| 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 |
| ClinicalTrials.gov ID | NCT07654751 |
Interventions
- Breast Milk Sample Collection (Procedure)
Breast milk samples will be collected as per the schedule specified in protocol. - Guselkumab (Drug)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.