The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
242
Intravenous brazikumab on day 1, day 15, and day 43 followed by Subcutaneous brazikumab every 4 weeks beginning on day 71 through Week 50
Intravenous placebo on day 1, day 15, and day 43 followed by Subcutaneous placebo every 4 weeks beginning on Day 71 through Week 50.
Percentage of participants with clinical remission
Clinical remission defined as: Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Time frame: at Week 10
Percentage of participants with sustained clinical remission
Sustained clinical remission defined as Modified Mayo Score (mMS): Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Time frame: at both Week 10 and Week 54
Percentage of participants with CS-free clinical remission
CS-free clinical remission defined as mMS: Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
Time frame: at Week 54 for patients who are CS-free for at least the last 12 weeks before the assessment at Week 54
Percentage of participants with clinical response
Clinical response is defined as Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1
Time frame: at Week 10
Percentage of participants with endoscopic improvement
Endoscopic improvement is defined as Endoscopy subscore ≤ 1
Time frame: at Week 10
Serum concentration of brazikumab
Pharmacokinetics: concentration of brazikumab in serum
Time frame: through Week 68
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Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Chula Vista, California, United States
Research Site
Lancaster, California, United States
Research Site
Lincoln, California, United States
Research Site
Mission Hills, California, United States
Research Site
Poway, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Clearwater, Florida, United States
...and 115 more locations
For each dose level: LS mean of Mayo score and brazikumab pre-dose blood concentration
Exposure-response
Time frame: at 12 weeks after dosing
Incidence of anti-drug antibodies
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Time frame: through week 68
Number and percentage of participants with adverse events
Number and percentage of patients with reported adverse events.
Time frame: through Week 68
Percentage of participants with potentially clinically significant changes in laboratory values
Percentage of patients with potentially clinically significant changes in hematology, clinical chemistry, urinalysis.
Time frame: through Week 68
Percentage of participants with potentially clinically significant changes in vital signs
Percentage of patients with potentially clinically significant changes in systolic and diastolic blood pressure, and pulse rate.
Time frame: through Week 68
Clinically relevant abnormal findings at physical exam
New or aggregated clinical relevant abnormal medical finding are reported as AE unless related to the disease under study
Time frame: through Week 68
Percentage of participants with potentially clinically significant changes in ECGs
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Time frame: through Week 68