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.
Percentage of Participants With Clinical Remission at Week 12
Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, \& endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease \[erythema, decreased vascular pattern\], 2=Moderate disease \[marked erythema, absent vascular pattern, friability, erosions\], 3=Severe disease \[spontaneous bleeding, ulceration\]). Percentages have been rounded off.
Time frame: At Week 12
Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as decrease from baseline in mMS of ≥ 2 \& ≥ 30% reduction from baseline and also decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease. Rectal bleeding scores are: 0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed. Percentages have been rounded off.
Time frame: At Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Endoscopic improvement was defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability). Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off.
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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
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
Henry Ford Health System
Novi, Michigan, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
...and 55 more locations
Time frame: At Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission was defined as a Mayo endoscopy subscore of 0. Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern and mild friability\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off.
Time frame: At Week 12
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; Any new disease or exacerbation of existing disease; Recurrence of an intermittent medical condition not present at baseline; Any deterioration in a laboratory value or other clinical test, associated with symptoms or leads to change in study treatment or concomitant treatment or discontinuation from study treatment; AEs related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
Time frame: Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Serum Concentration of Vixarelimab at Specified Timepoints
Time frame: Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks)
Induction: Number of Participants With Anti-drug Antibodies (ADAs)
Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to vixarelimab was determined by summing the ADA-positive participants across all timepoints.
Time frame: Baseline and post-baseline visits (up to 12 weeks)