Brazikumab for Ulcerative Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ulcerative Colitis+1 MoreBrazikumab - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, brazikumab, to see if it is effective and safe for people with moderate to severe ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis
  • Inflammatory Bowel Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 22 Secondary · Reporting Duration: at Week 54 for patients who are CS-free for at least the last 12 weeks before the assessment at Week 54

Week 12
For each dose level: LS mean of CDAI and brazikumab pre-dose blood concentration
For each dose level: LS mean of Mayo score and brazikumab pre-dose blood concentration
at Week 10
Percentage of participants with clinical remission
Percentage of participants with clinical response
Percentage of participants with endoscopic improvement
Percentage of patients with clinical remission
Percentage of patients with clinical response
Percentage of patients with endoscopic improvement
Week 54
Percentage of participants with CS-free clinical remission
Percentage of patients with CS-free clinical remission
Week 54
Percentage of participants with sustained clinical remission
Percentage of patients with sustained clinical remission
through Week 68
Clinically relevant abnormal findings at physical exam
Number and percentage of participants with adverse events
Number and percentage of patients with adverse events
Percentage of participants with potentially clinically significant changes in ECGs
Percentage of participants with potentially clinically significant changes in laboratory values
Percentage of participants with potentially clinically significant changes in vital signs
Percentage of patients with potentially clinically significant changes in ECGs
Percentage of patients with potentially clinically significant changes in laboratory values
Percentage of patients with potentially clinically significant changes in physical exams
Percentage of patients with potentially clinically significant changes in vital signs
Serum concentration of brazikumab
through week 68
Incidence of anti-drug antibodies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Brazikumab Dose 2
1 of 3
Brazikumab Dose 1
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

256 Total Participants · 3 Treatment Groups

Primary Treatment: Brazikumab · Has Placebo Group · Phase 2

Brazikumab Dose 2
Drug
Experimental Group · 1 Intervention: Brazikumab · Intervention Types: Drug
Brazikumab Dose 1
Drug
Experimental Group · 1 Intervention: Brazikumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brazikumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 54 for patients who are cs-free for at least the last 12 weeks before the assessment at week 54

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,857,206 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
356 Patients Enrolled for Ulcerative Colitis
Kathy BohannonStudy DirectorAstraZeneca
3 Previous Clinical Trials
1,254 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
165 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening.
The patient has UC that extends proximal to the rectum.
You have a daily average of at least 1 mMS stool and 1 mMS rectal bleeding.
You have a full colonoscopy within 14 days prior to randomization.
You are able to provide informed consent.

Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%