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NCT07654751 · ClinicalTrials.gov registry record · Phase 4
A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
A Phase 4 study, sponsored by Janssen Research & Development.
- Not yet
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT07654751: Clinical Trial Phase 4 study, sponsored by Janssen Research & Development.
NCT07654751 is a Phase 4 study that has not yet begun recruiting, run by Janssen Research & Development. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07654751, a Phase 4 study, has not yet begun recruiting, sponsored by Janssen Research & Development.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q4W maintenance regimen will be reported.
Interventions
- DRUG Guselkumab
- PROCEDURE Breast Milk Sample Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 4 |
What is known before NCT07654751 opens enrollment
NCT07654751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Guselkumab is the first listed.
NCT07654751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07654751 about?
NCT07654751 is a clinical study titled "A 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.
What is the current status of trial NCT07654751?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2026-06-15. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07654751?
The interventions under investigation include: Guselkumab (DRUG), Breast Milk Sample Collection (PROCEDURE).
Who is sponsoring clinical trial NCT07654751?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07654751's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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