Recruiting
Phase 4

Guselkumab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07654751

Conditions

Psoriasis

Colitis, Ulcerative

Crohn Disease

Arthritis, Psoriatic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breast Milk Sample Collection

Guselkumab

Study Details

Brief 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. 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

Study ID

NCT07654751

Start date

Aug 7, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Breast Milk Sample Collection

Breast milk samples will be collected as per the schedule specified in protocol.

Guselkumab

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.

Primary outcome measure

  • Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) [ Time Frame: Up to Day 29 ]
  • Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen) [ Time Frame: Up to Day 57 ]
  • Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen [ Time Frame: Up to Day 29 ]
  • Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen [ Time Frame: Up to Day 57 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.