QUASARGuselkumab for Active Ulcerative Colitis
This study aims to evaluate the effectiveness and safety of Guselkumab in treating adults with active ulcerative colitis by assessing clinical response and remission over a 44-week period.
Placebo
+ Guselkumab
Colitis+5
+ Colitis, Ulcerative
+ Colonic Diseases
Treatment Study
Summary
Study start date: September 26, 2019
Actual date on which the first participant was enrolled.This study is focused on testing the effectiveness and safety of a medication called guselkumab for people with moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. The study aims to find out if guselkumab can help reduce the symptoms and improve the quality of life for those affected by this condition. By evaluating the medication's performance, the study could provide a new treatment option that might better manage symptoms and potentially lead to remission in patients, addressing an important need for those suffering from this chronic illness. Participants in this study will receive either guselkumab or a placebo, with neither the participants nor the researchers knowing who receives which, ensuring unbiased results. The medication is likely administered through injections. The study will measure how well participants respond to the treatment by looking at their modified Mayo score, which assesses stool frequency, rectal bleeding, and endoscopic findings. These measures help determine if the treatment results in a clinical response or remission. The trial will assess outcomes at different stages, with a focus on improvements by week 12 and week 44. This structured approach helps ensure the safety and effectiveness of the treatment are thoroughly evaluated.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1064 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.8 intervention groups are designated in this study
37.5% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
PlaceboGroup III
PlaceboGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 392 locations
Om Research LLC
Lancaster, United StatesUCLA
Los Angeles, United StatesPeak Gastroenterology Associates 1
Colorado Springs, United States