The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
This study consists of two periods: 1. An induction period which will test the induction of clinical remission; 2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Vixarelimab will be administered as per the schedule specified in the respective arms.
Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.
Proportion of Participants With Clinical Remission
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.
Time frame: Week 12
Proportion of Participants With Clinical Response
Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.
Time frame: Week 12
Proportion of Participants With Endoscopic Improvement
Endoscopic improvement is defined as a mayo endoscopy subscore of ≤ 1. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Time frame: Week 12
Proportion of Participants With Endoscopic Remission
Endoscopic remission is defined as a mayo endoscopy subscore of 0. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Time frame: Week 12
Number of Participants With Adverse Events (AEs) by Severity
The AEs will be graded according to the Division of AIDS (DAIDS) table for grading the severity. The toxicity level is graded from grade 1 (lowest toxicity) to 4 (highest toxicity).
Time frame: Up to Week 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gulf Coast Gatroenterology
Fairhope, Alabama, United States
OM Research LLC - Camarillo - ClinEdge - PPDS
Camarillo, California, United States
UCLA Clinical and Translational Research Center
Los Angeles, California, United States
Facey Medical Foundation - Mission Hills
Mission Hills, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Regenerate Primary Medical
Miami, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Orlando Gastroenterology, P.A.
Orlando, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
...and 112 more locations
Serum Concentration of Vixarelimab
Time frame: Up to Week 56
Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab
Time frame: Up to Week 56