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Looking for participantsPhase3

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06663332

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Guselkumab (drug)
How long the study runs
Study runs about 88 months (dates as stated)
About the drug or intervention
Guselkumab — drug: Guselkumab will be administered as subcutaneous injection.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
3 Years and over
Who
All
Number of participants
196
Started
2024-10-29
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for crohns disease
  • • Phase3 - 196 participants
  • • The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA)

Who can take part?

  • • Ages 3 Years and over
  • • Diagnosed with crohns disease

Where?

  • • Sheffield - Sheffield Children's Hospital
  • • Stoke-on-Trent - Royal Stoke University Hospital
  • • Stoke-on-Trent - Haywood Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Crohns DiseaseColitis, UlcerativeArthritis, PsoriaticArthritis, Juvenile

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 3 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ completed the dosing planned in the primary pediatric guselkumab study
  • ✓ received benefit from continued guselkumab therapy in the opinion of the investigator
  • ✓ for, the study and is willing to allow the child to participate in the study

What the study is looking for

  • ✓Must have completed the dosing planned in the primary pediatric guselkumab study
  • ✓Must have received benefit from continued guselkumab therapy in the opinion of the investigator

Who cannot take part

  • ✗Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed...
  • ✗Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for...
  • ✗Are pregnant, nursing, or planning pregnancy or fathering a child
  • ✗Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
See the full criteria
Inclusion Criteria: * Must have completed the dosing planned in the primary pediatric guselkumab study * Must have received benefit from continued guselkumab therapy in the opinion of the investigator * Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure * Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate. Exclusion Criteria: * Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication * Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication * Are pregnant, nursing, or planning pregnancy or fathering a child * Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention * Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Where Is This Study? (3 UK sites)

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

Haywood Hospital

Stoke-on-Trent ST6 7AG, United Kingdom

Recruiting

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09