Guselkumab for Pediatric Ulcerative Colitis
(QUASAR Jr Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing guselkumab, a medication that reduces inflammation, in children with severe ulcerative colitis who have already shown improvement with earlier treatment. It works by blocking a protein to reduce immune system-related swelling and irritation. Guselkumab has shown benefit in treating inflammatory conditions, with reports of substantial improvement in patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug Guselkumab different from other treatments for pediatric ulcerative colitis?
Guselkumab is unique because it targets a specific protein involved in inflammation, which is different from other treatments like steroids or anti-TNF drugs that have broader effects. This targeted approach may offer a new option for children with ulcerative colitis who do not respond to existing therapies.12345
What data supports the effectiveness of the drug Guselkumab for pediatric ulcerative colitis?
Guselkumab has been studied for its effectiveness in adults with ulcerative colitis, showing promise in patients who did not respond well to other treatments. While specific data for children is limited, similar biologic drugs have been used successfully in pediatric ulcerative colitis, suggesting potential benefits.13467
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for children and teenagers with moderately to severely active ulcerative colitis, a type of inflammatory bowel disease. Participants must have shown some response to earlier treatment phases to qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Induction
Participants receive guselkumab intravenously or subcutaneously based on their body weight during the 12-week open-label induction phase
Double-blind Maintenance
Week 12 responders are randomized to receive guselkumab dose regimen 1 or 2 subcutaneously based on their body weight up to Week 56
Open-label Maintenance
Week 12 non-responders enter an open-label maintenance phase to receive guselkumab subcutaneously based on their body weight up to Week 56
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Guselkumab
Guselkumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University