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Monoclonal Antibodies

Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active 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 at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54

Summary

This trial is testing brazikumab, a drug that reduces inflammation in the colon. It is aimed at patients with severe Ulcerative Colitis who may not respond to usual treatments. Brazikumab works by blocking proteins that cause inflammation, helping to calm the immune system.

Eligible Conditions
  • Colitis
  • Inflammatory Bowel Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants with clinical remission
Secondary study objectives
Clinically relevant abnormal findings at physical exam
For each dose level: LS mean of Mayo score and brazikumab pre-dose blood concentration
Incidence of anti-drug antibodies
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Brazikumab Dose 2Experimental Treatment1 Intervention
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
Group II: Brazikumab Dose 1Experimental Treatment1 Intervention
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through week 50
Group III: PlaceboPlacebo Group1 Intervention
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous every 4 weeks beginning on day 71 through Week 50.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brazikumab
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,369 Total Patients Enrolled
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
164 Total Patients Enrolled

Media Library

Brazikumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03616821 — Phase 2
Inflammatory Bowel Disease Research Study Groups: Brazikumab Dose 2, Brazikumab Dose 1, Placebo
Inflammatory Bowel Disease Clinical Trial 2023: Brazikumab Highlights & Side Effects. Trial Name: NCT03616821 — Phase 2
Brazikumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03616821 — Phase 2
~33 spots leftby Dec 2025
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