No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
196 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for
This trial is looking for children and adolescents with certain types of arthritis or inflammatory bowel disease who have benefited from an earlier treatment with guselkumab. Participants will continue receiving this medication to evaluate its long-term safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have completed the main study with guselkumab.
I have benefited from guselkumab in the opinion of my doctor.
I am not pregnant or nursing.
I agree to use effective contraception if I can get pregnant.
You may not be able to join if
I am 18 years or older and live in a country where the medicine is available for adults.
I am under 18 years old and live in a country where the medicine is available for children.
I am pregnant, nursing, or planning to become pregnant.
I have taken any medications that are not allowed before this study.
I have a medical condition that my doctor thinks would not be in my best interest to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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City
State
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Status
Eligibility 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 ch…
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
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