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

NCT07654751 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: CNTO1959ISD4001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (4)

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

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

  Up to Day 29

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

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

  Up to Day 57

• Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen

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

  Up to Day 29

• Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen

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

  Up to Day 57

Study Arms (2)

Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen

EXPERIMENTAL

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.

Procedure: Breast Milk Sample Collection; Drug: Guselkumab

Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen

EXPERIMENTAL

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.

Procedure: Breast Milk Sample Collection; Drug: Guselkumab

Interventions

Breast Milk Sample Collection PROCEDURE

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

Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen; Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen

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.

Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen; Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Psoriasis; Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)