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RecruitingPhase 3

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

CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the long-term safety of guselkumab, given as a shot under the skin. It is for children and teens with moderate to severe active ulcerative colitis or Crohn’s disease, which cause swelling in the gut, or juvenile psoriatic arthritis, which affects the joints.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Finished all planned doses in the main children’s guselkumab study.
  • The study doctor believes continued guselkumab treatment has helped you.
  • Cannot become pregnant, or can become pregnant but are not sexually active, avoid sex, or use highly effective birth control. If you can become pregnant, you must agree to use highly effective birth control during treatment and for 12 weeks after the last dose.
  • A parent or legal representative must sign a form showing they understand the study and allow you to join.
  • Children who can understand the study, usually age 7 or older, must also agree to join. When they reach legal adulthood, they will have a chance to sign their own consent form.

Who can't join

  • You are 18 or older, and guselkumab has been approved in your country for adults with your condition for at least 2 years.
  • You are under 18, and guselkumab has been approved in your country for children with your condition for at least 2 years.
  • You are pregnant, breastfeeding, or planning to become pregnant or father a child.
  • You used a treatment that is not allowed before your planned first dose in this extension study.
  • You work for the study doctor or site and are directly involved in their studies, or you are a family member of these employees or the study doctor.
  • The study doctor believes a health condition makes joining the study a poor choice for you or could interfere with the study’s tests.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (6)

GA

IN

OH

TX

UT