Arthritis, Juvenile · Arthritis, Psoriatic · Colitis, Ulcerative · Crohns Disease
Long-term Guselkumab Safety in Pediatric Crohn's, Colitis, or Psoriatic Arthritis
This phase 3 extension study is examining the long-term safety of injected guselkumab in pediatric participants previously treated in a guselkumab study for Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis.
Registry title: A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
5 recruiting U.S. sites ↓Study at a glance
- Age
- 3 Years and older
- Treatment
- Guselkumab
- Design
- Non Randomized
- Central study contact
- Study Contact844-434-4210Participate-In-This-Study1@its.jnj.com
- Sponsor
- Janssen Research & Development, LLC
Research question
What is the long-term safety of subcutaneous guselkumab in pediatric participants with Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis?
Participant snapshot
Who the study is looking for
- The study is looking for participants age 3 years or older who previously took part in a primary pediatric guselkumab study.
- Participants must have completed the planned dosing in that primary pediatric guselkumab study.
- The investigator must believe the participant received benefit and should continue guselkumab.
- The study includes participants with moderately to severely active Crohn's disease or ulcerative colitis, or with juvenile psoriatic arthritis.
- Recruiting locations are listed in the United States and multiple other countries, but the study team must confirm whether a specific site is open.
Participation overview
What participation may involve
Participants continue guselkumab by injection under the skin in a long-term extension, with safety assessed through treatment-emergent adverse-event reporting. What participation may involve: - Receive guselkumab by subcutaneous injection. - Receive guselkumab every 4 or 8 weeks according to the applicable study group. - Have treatment-emergent adverse events reported for the long-term safety assessment.
Study interventions
What participants may receive or do
- Guselkumab: Participants continue guselkumab as an injection under the skin, generally every 4 or 8 weeks according to their prior study group and the extension-study rules.
Study design
How the comparison works
This is a phase 3, open-label, non-randomized long-term extension with parallel groups receiving guselkumab every 4 or 8 weeks. Participants are not randomly assigned; their dosing group is determined by their primary study group and the extension-study rules. The extension study has no masking, meaning participants and study personnel know that guselkumab is being given. The registry lists two guselkumab dosing groups and does not list a separate untreated or active-comparator group. No placebo intervention or placebo group is listed for this extension study.
Reported activities
Procedures and tests
- Guselkumab is administered by subcutaneous injection.
- Treatment-emergent adverse events are reported as the primary safety assessment.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have completed the dosing planned in a primary pediatric guselkumab study.
- The investigator must believe the participant received benefit from continued guselkumab therapy.
- A participant must either not be able to become pregnant or, if able, meet the study's sexual-activity, abstinence, or highly effective contraception requirements through 12 weeks after the last dose.
- A parent or legally acceptable representative must provide consent; participants able to understand the study must provide assent, typically from age 7, and adolescents reaching adulthood can sign an adult consent form.
Possible reasons someone may not be able to join
- A participant age 18 or older is excluded in a country where two years have passed since marketing authorization for the relevant adult indication.
- A participant younger than 18 is excluded in a country where two years have passed since marketing authorization for the relevant pediatric indication.
- People who are pregnant, nursing, planning pregnancy, or planning to father a child are excluded.
- Taking a therapy that the protocol disallows before the first extension-study dose is an exclusion.
- Study-site or investigator employees directly involved in relevant studies, and their family members, are excluded.
- The investigator may exclude someone if a condition makes participation contrary to the participant's interests or could prevent, limit, or confuse the required assessments.
Important unknowns
What the record does not make clear
- The registry does not state how often in-person or other study visits occur.
- The primary safety outcome is measured for up to 6 years and 9 months, but the record does not separately state how long an individual participant will remain in the study.
- The record does not say which ongoing medicines or other treatments may continue with guselkumab.
- The criteria mention disallowed therapies before the first extension dose but do not identify them or give timing requirements.
- The registry does not describe rescue treatment if the participant's condition worsens.
- The registry does not state whether participants with Crohn's disease or ulcerative colitis need endoscopy or other gastrointestinal procedures.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation or reimbursement.
- The registry lists study sites but does not describe travel or lodging support.
- The registry does not say whether any visits or assessments can be completed remotely.
- The registry does not state whether guselkumab will remain available after extension-study participation ends.
- The registry lists recruiting sites, but it does not confirm whether every disease cohort and dosing group remains open at each site.
Before contacting the site
Questions for the study team
- Which guselkumab dosing interval would apply based on the primary study, and could that interval change?
- How long would participation last, and how often are study visits?
- What examinations, laboratory tests, imaging, endoscopies, questionnaires, or samples are required?
- Which medicines or therapies are disallowed, and are there any washout periods before the first extension dose?
- What happens if the participant's condition worsens or guselkumab must be stopped?
- Which study and travel costs are covered, and is compensation or reimbursement available?
- Is the relevant disease cohort currently recruiting at the preferred site?
Before changing care
Questions for your gastroenterologist
- How stable is the Crohn's disease or ulcerative colitis now, and what signs would suggest that continuing the current approach is no longer appropriate?
- Would any current medicines need to change before or during the study, and what risks could those changes create?
- What approved treatment alternatives are available if continuing guselkumab through this extension is not pursued?
- How would you coordinate disease monitoring and urgent care with the research team if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- CNTO1959ISD3001
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Other
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Guselkumab (Every 8 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.
Interventions: Drug: Guselkumab
Experimental
Guselkumab (Every 4 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.
Interventions: Drug: Guselkumab
Interventions
Drug
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Eligibility
3 Years and older
All
Not accepted
Inclusion criteria (4)
- Must have completed the dosing planned in the primary pediatric guselkumab studyRegistry-derived · unreviewed
- Must have received benefit from continued guselkumab therapy in the opinion of the investigatorRegistry-derived · unreviewed
- 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 exposureRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (6)
- 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 indicationRegistry-derived · unreviewed
- Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indicationRegistry-derived · unreviewed
- Are pregnant, nursing, or planning pregnancy or fathering a childRegistry-derived · unreviewed
- Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study interventionRegistry-derived · unreviewed
- 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 investigatorRegistry-derived · unreviewed
- 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 assessmentsRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
Time frame: Up to 6 years and 9 months
Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.
Recruiting locations in the United States
Children's Center for Digestive Healthcare
RecruitingAtlanta, Georgia, 30342, United States
Emory University
RecruitingAtlanta, Georgia, 30322, United States
Riley Hospital for Children
RecruitingIndianapolis, Indiana, 46202, United States
Cincinnati Children's Hospital Medical Center
RecruitingCincinnati, Ohio, 45229, United States
University of Utah
RecruitingSalt Lake City, Utah, 84113, United States
This study also lists 44 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 29, 2024
- Primary completion
- Dec 12, 2031
- Overall completion
- Feb 25, 2032
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.