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: Recruiting

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Conditions

Arthritis, Psoriatic
Colitis, Ulcerative
Crohn Disease
Psoriasis

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

First listed: Jun 17, 2026
Start date: Aug 7, 2026
Status verified: Aug 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.