A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07654751
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen
    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.
  • Experimental: Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen
    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.

Primary Outcome Measure

Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) [ Time Frame: Up to Day 29 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
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GastroenterologyInflammatory bowel diseaseAutoimmune diseaseDermatologyRheumatology
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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