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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

INTREPID OLE Trial Summary

This trial will allow participants in a previous trial to receive the drug brazikumab, so that doctors can observe its long-term safety.

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease

INTREPID OLE 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
Electrocardiogram
Percentage of patients with potentially clinically significant changes in laboratory values
+1 more

INTREPID OLE 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
4,274 Previous Clinical Trials
288,613,403 Total Patients Enrolled
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
388 Total Patients Enrolled

Media Library

Brazikumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03961815 — Phase 3
Crohn's Disease Research Study Groups: Brazikumab Induction Dose, Brazikumab Maintenance Dose
Crohn's Disease Clinical Trial 2023: Brazikumab Highlights & Side Effects. Trial Name: NCT03961815 — Phase 3
Brazikumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961815 — Phase 3

Frequently Asked Questions

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

How many patients are being given this experimental medication?

"This particular trial has completed recruitment and is no longer searching for participants. The study was first posted on January 6th, 2020 and last updated November 7th, 2022. For other similar studies, 275 are currently enrolling patients with Crohn Disease while 4 are enrolling patients for Brazikumab Induction Dose."

Answered by AI

Is there a danger in using Brazikumab Induction Dose to help patients?

"There is pre-existing evidence that suggests Brazikumab Induction Dose is safe, therefore it received a score of 3."

Answered by AI

Is there still room for new patients in this clinical trial?

"According to the latest information available on clinicaltrials.gov, this study is no longer recruiting patients. Although it has not been updated in over a year, there are nearly 300 other medical trials that are still looking for participants."

Answered by AI

How do I sign up for this opportunity to help with this research?

"This clinical trial is testing a new treatment for Crohn's disease. The study requires that patients be between 18 and 80 years old. They are looking to enroll 161 participants in total."

Answered by AI

Is this an innovative research project?

"There are 4 studies currently underway for Brazikumab Induction Dose in 125 cities and 26 countries. The first study began in 2018. 256 patients participated in the Phase 2 drug approval stage of the trial, which was sponsored by AstraZeneca. Since 2018, two more trials have been completed."

Answered by AI

Does this study have an age limit?

"This trial requires that individuals be aged between 18 and 80 to participate."

Answered by AI

How does the efficacy of Brazikumab Induction Dose compare to other drugs in its class?

"4 clinical trials are still active and investigating the effects of Brazikumab Induction Dose. Out of these 4, 2 are currently in Phase 3. Additionally, while a few of the trials take place in Busan and Pennsylvania, there are 922 different locations around the world conducting these Brazikumab Induction Dose trials."

Answered by AI

Are there many locations where this test is being conducted within our state?

"To reduce participant burden, this clinical trial is enrolling at 18 sites across Brownsburg, Vaughan, New Westminster and 15 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Open-label Extension Study of Brazikumab in Crohn's Disease
2020. "Open-label Extension Study of Brazikumab in Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03961815.
~3 spots leftby May 2025
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