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Monoclonal Antibodies
Brazikumab low dose for Crohn's Disease (INTREPID Trial)
Phase 2 & 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 endoscopic response at week 12, endoscopic remission at week 52
Summary
This trial is testing brazikumab, a medication that reduces inflammation in the intestines. It targets people with severe Crohn's Disease who have not responded well to other treatments. Brazikumab works by blocking a protein that causes inflammation, helping to improve symptoms and heal the intestines.
Eligible Conditions
- Crohn's Disease
- Inflammatory Bowel Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ endoscopic response at week 12, endoscopic remission at week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~endoscopic response at week 12, endoscopic remission at week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Stage 1. Exposure-response
Stage 1. Incidence of anti-drug antibodies
Stage 1. Number and percentage of patients with adverse events
+29 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: (Stage 2) Brazikumab low doseExperimental Treatment1 Intervention
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48
Group II: (Stage 2) Brazikumab high doseExperimental Treatment1 Intervention
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Group III: (Stage 1) Brazikumab low doseExperimental Treatment1 Intervention
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Group IV: (Stage 1) Brazikumab high doseExperimental Treatment1 Intervention
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Group V: (Stage 2) Humira®Active Control1 Intervention
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
Group VI: (Stage 1) PlaceboPlacebo Group1 Intervention
Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,568 Total Patients Enrolled
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer in the past, but certain types of cancer may be allowed.You are currently dependent on a special liquid diet or IV nutrition.You have received a bone marrow or organ transplant in the past.Qualifications for being eligible to participate in the study.You have had an allergic reaction to the study drug or any of its ingredients, or other similar treatments.You had a serious colon problem called toxic megacolon within the last 3 months.You have a hole between your intestines and your skin or bladder.You have had or currently have certain medical conditions related to your digestive system.You have a medical condition that makes you more likely to get an infection, such as HIV, or have had your spleen removed.You have had significant heart problems within the past 6 months.You have Crohn's disease and are currently experiencing severe complications such as a blocked intestine or pre-surgery anticipation within the next 6 months.You have been experiencing symptoms of Crohn's disease in your small or large intestine for at least 3 months before being screened for the trial.You have other medical conditions that are not related to CD and cannot be controlled with standard treatment.You have a history of long-term use of painkillers or drugs and/or alcohol abuse.You have not responded well to standard or previous treatments for your condition, or you have become dependent on corticosteroids to manage your symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: (Stage 1) Brazikumab high dose
- Group 2: (Stage 1) Brazikumab low dose
- Group 3: (Stage 1) Placebo
- Group 4: (Stage 2) Brazikumab high dose
- Group 5: (Stage 2) Brazikumab low dose
- Group 6: (Stage 2) Humira®
Awards:
This trial has 0 awards, including: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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