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

Published: 10/01/2026

General Information:

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Study Objective

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.

Phase of study
Other
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Eligibility:

Age
Adult (18+)
Gender
Female
Disease Type
Crohn's Disease
Ulcerative Colitis
Severity
Mild
Moderate
Severe
Eligibility Criteria

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
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Study Details:

Study description/explanation of participation:

  • The VENUS study is for women who are breastfeeding and receiving TREMFYA® (guselkumab) for at least one of the following conditions:
  • Ulcerative colitis (UC), Crohn’s disease (CD), Psoriasis or psoriatic arthritis (PsA),
  • This study is for scientific research purposes and is not related to your condition or how TREMFYA® works
  • It is a remote study, which means you will be able to participate entirely from your home
  • Your total participation will last about 8 or 12 weeks (2 or 3 months)
  • This will depend on how often you receive TREMFYA® injections

Description of treatment or intervention (mechanism of action):

  • You will continue receiving standard care from your treating physician
  • The study will not provide you with TREMFYA®, and you will continue receiving it as prescribed by your treating physician
  • You will virtually meet the study doctor/staff approximately 6-7 times over the phone or by video conference
  • They will ask you questions about your breast milk, overall health, and medications you are taking
  • You will provide 4-5 total breast milk samples to the study doctor/staff over 1-2 months
  • You can use your own breast pump, or the study doctor/staff can provide you with an electric pump to use throughout the study
  • You will be provided with instructions on how to collect, handle, store, and ship your breast milk samples to the study doctor/staff

Possible risks and side effects:

Participants will continue using TREMFYA as part of their standard medical care provided by their treating physician. Participating in this study is not expected to add additional risk beyond the risks you would normally have from receiving this treatment as part of your routine care. There may be risks to using TREMFYA that we do not know about.

The transfer of TREMFYA into human breast milk and daily exposure to breastfed infants is currently unknown, though expected to be low.

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Contact Information:

Site Locations

University of North Carolina at Chapel Hill 101 Manning Dr. Chapel Hill, North Carolina 27514
Jenn Barr
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