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A Long-term Extension Study of Guselkumab in Pediatric Participants
EU CTIS ID: 2023-509560-16-00
What this study is testing
To evaluate the long-term safety of guselkumab in pediatric participants with moderately to severely active ulcerative colitis (UC), or with moderately to severely active Crohn’s disease, or with juvenile psoriatic arthritis (jPsA)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Must have completed the dosing planned in the primary pediatric guselkumab study.
- 2. Received benefit from continued guselkumab therapy in the opinion of the investigator.
- 3. 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.
- 4. Parent(s) or their legally designated representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- 5. Must be willing and able to adhere to the lifestyle restrictions specified in the protocol.
You likely can't join if
- 1. Is ≥18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication. Is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication.
- 2. Are pregnant, nursing, or planning pregnancy or fathering a child.
- 3. Taken any disallowed therapies before the planned first LTE dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Canada
- Brazil
- Israel
- Mexico
- Japan
- Australia
- Korea, Republic of
- United States
- United Kingdom
- Argentina
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Canada; Brazil; Israel; Mexico; Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.