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Brazikumab for Ulcerative Colitis (Expedition Trial)
Expedition Trial Summary
This trial is testing a new drug, brazikumab, to see if it is effective and safe for people with moderate to severe ulcerative colitis.
- Ulcerative Colitis
- Inflammatory Bowel Disease
Expedition Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Expedition Trial Design
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Who is running the clinical trial?
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- You have had symptoms of ulcerative colitis for at least 3 months before the screening.
- Group 1: Brazikumab Dose 2
- Group 2: Brazikumab Dose 1
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this scientific research open to citizens aged 60 or over?
"This trial necessitates that participants are younger than 80 years old and older than the legal age of consent."
What potential adverse effects are associated with Brazikumab treatment?
"Brazikumab received a score of 2 since Phase 2 studies have demonstrated initial safety profiles, though there is yet to be any data confirming its efficacy."
What is the current number of locations offering this trial?
"Currently, this study is taking place in 26 sites around the nation. These locations include Stafford, Phoenix and Greenville as well as many others to choose from. In order to minimize travel needs when enrolling, participants should select a site close by them."
Is this medical experiment pioneering a new procedure?
"Brazikumab has had an impressive research history since 2018, with 4 ongoing trials across 125 cities and 26 countries. AstraZeneca initially sponsored the first trial of Brazikumab which concluded its Phase 2 clinical evaluation stage after 256 patients participated. Since then, 18323 additional studies have been conducted."
Are there currently any opportunities to join this research endeavor?
"According to the clinicaltrials.gov platform, this research is actively seeking volunteers. The trial was published on August 7th 2018 and has recently been updated as of November 2nd 2022."
Who are the ideal participants in this experimental research?
"This clinical experiment seeks 256 recruits between the ages of 18 and 80 that have been diagnosed with inflammatory bowel disease (IBD). The exact conditions for entry are: Being aged 18 to 80 years old, having manifested symptoms indicative of ulcerative colitis (UC) for a minimum duration of 3 months prior to screening, evidence demonstrating UC extends proximal to their rectum by at least 15 cm, an average daily mMS Stool Frequency subscore ≥ 1 AND Average daily mMS Rectal Bleeding subscore ≥ 1 , as well as a Modified Mayo endoscopic subscore of ≥ 2 based on full colonoscopy performed within"
How many participants are currently engaged in this clinical research?
"Affirmative, according to information hosted on clinicaltrials.gov the trial is actively recruiting. It was initially listed on August 7th 2018 and most recently amended on November 2nd 2022. 256 individuals in total need to be recruited from 26 different locations."
What are the fundamental aims of this trial?
"This clinical trial, which is designed to evaluate outcomes over a 10-week period, has the primary objective of measuring Percentage of participants with clinical remission. Secondary objectives include assessing Percentage of patients with CS-free clinical remission (as defined by mMS: Endoscopy subscore = 0 or 1; Rectal bleeding subscore = 0; Stool frequency subscore = 0 or 1 and at least a one point decrease from baseline), Percentage of subjects with clinical response (defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in rectal bleeding score ≥1 point from baseline or a score of"
Are there any other experiments that have been conducted with Brazikumab?
"Currently, 4 Brazikumab trials are underway. Of these ongoing studies, two have advanced to Phase 3. While the majority of progress is in Busan and Pennsylvania, there are 922 research sites scattered around the world running investigations into this drug's efficacy."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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