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Brazikumab Induction Dose 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 through week 70
Awards & highlights

Expedition Trial Summary

This trial is for participants who were in a previous trial testing the safety and efficacy of brazikumab. There are no formal hypotheses being tested, but the safety and efficacy data from this study will be used in regulatory product submissions.

Eligible Conditions
  • Ulcerative Colitis

Expedition Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 70
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 70 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and percentage of patients with adverse events
Percentage of patients with potentially clinically significant changes in ECGs
Percentage of patients with potentially clinically significant changes in laboratory values
+2 more

Expedition Trial Design

2Treatment groups
Experimental Treatment
Group I: Brazikumab Maintenance DoseExperimental Treatment1 Intervention
Administer at 4-week intervals through Week 52 Participants who receive IV induction dosing will be administered brazikumab SC at 4-week intervals starting Week 12 through Week 52
Group II: Brazikumab Induction DoseExperimental Treatment1 Intervention
Administer at Week 0, Week 4, and Week 8

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,729 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
433 Patients Enrolled for Ulcerative Colitis
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
349 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
242 Patients Enrolled for Ulcerative Colitis

Media Library

Brazikumab Induction Dose Clinical Trial Eligibility Overview. Trial Name: NCT04277546 — Phase 2
Ulcerative Colitis Research Study Groups: Brazikumab Maintenance Dose, Brazikumab Induction Dose
Ulcerative Colitis Clinical Trial 2023: Brazikumab Induction Dose Highlights & Side Effects. Trial Name: NCT04277546 — Phase 2
Brazikumab Induction Dose 2023 Treatment Timeline for Medical Study. Trial Name: NCT04277546 — Phase 2

Frequently Asked Questions

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

Does this scientific experiment have any vacancies in its participant roster?

"Per the information featured on clinicaltrials.gov, this research project is not actively enrolling participants at this time; it was initially posted in March 2020 and last updated November 2022. Notwithstanding, there are 410 different studies currently seeking patient involvement."

Answered by AI

Is this trial pioneering a new method of treatment?

"Currently, 4 trials are running for Brazikumab Induction Dose in over 125 cities and 26 nations. Back in 2018, AstraZeneca initiated the first study which included 256 participants while going through Phase 2 drug approval. Since then, two other studies have concluded their research journey."

Answered by AI

How many participants is this research endeavor accommodating?

"Regrettably, this investigation is no longer recruiting participants. It was first advertised on the 3rd of March 2020 and last modified 11th September 2021. Though, there are currently 406 trials for colitis and 4 studies utilising Brazikumab Induction Dose that are still accepting volunteers."

Answered by AI

Are patients exposed to any risk when given the Brazikumab Induction Dose?

"Brazikumab Induction Dose was assessed a 2 out of 3 for safety due to the limited clinical evidence in its favor, as it is still undergoing Phase 2 trials."

Answered by AI

Is this research endeavor open to individuals aged thirty and above?

"This trial requires participants to be between 18 and 80 years of age; if the patient is under 18 or over 65, there exists a total of 419 other studies they are eligible for."

Answered by AI

In what locations has this medical trial been implemented?

"This clinical study is underway at 25 facilities, including Edmonton, Vaughan and Kissimmee. To reduce travel needs if you are accepted into this trial, select the closest medical centre to your residence."

Answered by AI

Could you provide an overview of the prior research that has been conducted surrounding Brazikumab Induction Dose?

"Currently, there are 4 experimental trials for Brazikumab Induction Dose with 2 reaching Phase 3. 922 clinical sites have been selected to test this medication, including locations in Busan and Pennsylvania."

Answered by AI

What criteria should potential participants possess to qualify for this research endeavor?

"This trial is seeking 165 participants, aged 18-80 years old, who have been diagnosed with colitis. To be eligible for the study, they must meet a series of criteria that includes having discontinued their participation in a previous study due to lack of efficacy after Week 10 and being willing to use contraception if applicable. Additionally all candidates are required to sign an Informed Consent Form (ICF) prior to any procedures and demonstrate adequate compliance during past studies before becoming accepted into this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Open-label Extension Study of Brazikumab in Ulcerative Colitis
2020. "Open-label Extension Study of Brazikumab in Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04277546.
~11 spots leftby Apr 2025
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