A Phase 3, Multicenter, Open-label, Basket, LTE Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis
Investigating Long-term Safety of an Investigational Medication in Children with Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis
Marian Pfefferkorn
Primary Investigator
Brief description of 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).
Detailed description of study
Participants will receive study intervention administration every 4 weeks (q4w), or every 8 weeks (q8w). Details of
the dosing regimen are shown in the table below. At the discretion of the investigator, participant, and guardian, and
after appropriate and documented training, the participant may self-administer study intervention or a guardian can
administer study intervention to the participant at home, according to local regulation
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Psoriatic Arthritis, Psoriatic Colitis, Ulcerative Crohns Disease, Riley
-
Age: 3 years or above
-
Gender: All
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
This study investigates the long-term safety of an investigational medication in children with conditions like Crohn's disease, ulcerative colitis, or juvenile psoriatic arthritis. Crohn's disease and ulcerative colitis are types of inflammatory bowel diseases that cause inflammation in the digestive tract, while juvenile psoriatic arthritis is a type of arthritis that affects children and is associated with the skin condition psoriasis.
Participants in this study will receive the investigational medication through injections either every 4 weeks or every 8 weeks. They may receive these injections at home, administered by themselves or a guardian, after proper training. This flexibility aims to accommodate the participants' and families' preferences and needs.
- Who can participate: Children who have completed a previous study with the investigational medication and benefited from it can join. They must be under 18 years old, and their parents or guardians need to consent to their participation.
- Study details: Participants will receive the investigational medication through injections, administered by themselves or a guardian at home, after receiving training. This allows for flexibility in how the study is conducted.
