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Monoclonal Antibodies

Brazikumab for Ulcerative Colitis (Expedition Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54
Awards & highlights

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.

Eligible Conditions
  • Ulcerative Colitis
  • Inflammatory Bowel Disease

Expedition Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with clinical remission
Secondary outcome measures
Clinically relevant abnormal findings at physical exam
For each dose level: LS mean of Mayo score and brazikumab pre-dose blood concentration
Incidence of anti-drug antibodies
+9 more

Expedition Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Brazikumab Dose 2Experimental Treatment1 Intervention
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
Group II: Brazikumab Dose 1Experimental Treatment1 Intervention
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through week 50
Group III: PlaceboPlacebo Group1 Intervention
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning on day 71 through Week 50.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brazikumab
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,179 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
248 Patients Enrolled for Ulcerative Colitis
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
164 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
57 Patients Enrolled for Ulcerative Colitis

Media Library

Brazikumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03616821 — Phase 2
Ulcerative Colitis Research Study Groups: Brazikumab Dose 2, Brazikumab Dose 1, Placebo
Ulcerative Colitis Clinical Trial 2023: Brazikumab Highlights & Side Effects. Trial Name: NCT03616821 — Phase 2
Brazikumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03616821 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~37 spots leftby Mar 2025