Guselkumab for Ulcerative Colitis
(QUASAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing guselkumab, a medication that targets inflammation, in patients with moderate to severe ulcerative colitis. Guselkumab works by attaching to a protein to reduce inflammation in the colon. This medication has shown promise in treating conditions like ulcerative colitis.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications, but it mentions that some medications might be prohibited. It's best to discuss your specific medications with the trial team.
Is Guselkumab safe for humans?
How is the drug guselkumab different from other treatments for ulcerative colitis?
What data supports the effectiveness of the drug Guselkumab for treating ulcerative colitis?
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 people with moderate to severe ulcerative colitis who haven't responded well to other treatments. Participants must have a confirmed diagnosis of UC and meet specific lab test requirements. Those with only rectal UC, less than 20 cm of colon affected, fistulas, or certain other bowel diseases can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Study 1
Participants receive guselkumab or placebo intravenously, with clinical response assessed at Week 12
Induction Study 2
Participants receive guselkumab or placebo intravenously, with clinical remission assessed at Week 12
Maintenance Study
Participants receive guselkumab or placebo subcutaneously every 4 or 8 weeks, with clinical remission assessed at Week 44
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