Guselkumab for Ulcerative Colitis
(ASTRO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an injectable medication called guselkumab on people with severe ulcerative colitis. It aims to see if blocking a protein that causes inflammation can help these patients achieve remission.
Do I need to stop my current medications to join the trial?
The trial information mentions that participants cannot be receiving prohibited medications and treatments, but it does not specify which ones. It's best to discuss your current medications with the trial team to see if any need to be stopped.
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 adults with moderately to severely active ulcerative colitis who haven't responded well to or can't tolerate standard treatments. They must have been diagnosed at least 12 weeks before the study starts and cannot be on certain medications, have recent or upcoming surgery that could affect results, just rectal UC, other types of colitis, Crohn's disease, or an active COVID-19 infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive guselkumab or placebo subcutaneous injections to evaluate efficacy and clinical remission
Extended Treatment
Continued treatment to assess long-term efficacy and safety, including endoscopic and symptomatic improvements
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Guselkumab
Guselkumab is already approved in United States, European Union for the following indications:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
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