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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06663332
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Research & Development, LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation	Janssen Research & Development, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile

Arms & Interventions

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.

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

Guselkumab will be administered as subcutaneous injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84113

Site Contact

[email protected]

844-434-4210