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NCT Number: NCT07654751

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.

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)

    Time frame: Up to Day 29

    Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q4W maintenance regimen will be reported.

  2. Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen)

    Time frame: Up to Day 57

    Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q8W maintenance regimen will be reported.

  3. Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen

    Time frame: Up to Day 29

    The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported.

  4. Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen

    Time frame: Up to Day 57

    The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

CNTO1959ISD4001: 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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