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Brazikumab Induction Dose for 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
No Placebo-Only Group
Summary
This trial allows individuals to continue using brazikumab to observe its ongoing safety and effectiveness. Brazikumab works by reducing inflammation, which can help improve symptoms in chronic conditions.
Eligible Conditions
- Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through week 70
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 70
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,716 Total Patients Enrolled
7 Trials studying Colitis
665 Patients Enrolled for Colitis
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
349 Total Patients Enrolled
1 Trials studying Colitis
242 Patients Enrolled for Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe inflammation in your colon or specific digestive disorders that could interfere with the study.You have had an organ or cell transplantation, except for a corneal transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Brazikumab Maintenance Dose
- Group 2: Brazikumab Induction Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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