Your session is about to expire
← Back to Search
Monoclonal Antibodies
Brazikumab Induction Dose for Crohn's Disease (INTREPID OLE Trial)
Phase 3
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
Pivotal Trial
Summary
This trial allows individuals to continue using brazikumab to ensure it remains safe over time. Brazikumab helps reduce inflammation, which can alleviate symptoms of certain diseases.
Eligible Conditions
- Crohn's Disease
- Inflammatory Bowel Disease
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
Electrocardiogram
Percentage of patients with potentially clinically significant changes in laboratory values
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
4,397 Previous Clinical Trials
289,121,638 Total Patients Enrolled
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
388 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a transplant of organs or cells, except for a corneal transplant.You are allergic to brazikumab or any of its ingredients.You currently have a diagnosis of certain conditions affecting your colon or bile ducts.
Research Study Groups:
This trial has the following groups:- Group 1: Brazikumab Induction Dose
- Group 2: Brazikumab Maintenance Dose
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger