The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Clinnova Research ( Site 1042)
Anaheim, California, United States
RECRUITINGPeak Gastroenterology Associates ( Site 1052)
Colorado Springs, Colorado, United States
RECRUITINGPercentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Time frame: Week 12
Percentage of Participants With One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.
Time frame: Up to approximately 12 months
Percentage of Participants Who Discontinued Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 12 months
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South Denver Gastroenterology, PC ( Site 1068)
Englewood, Colorado, United States
RECRUITINGNature Coast Clinical Research ( Site 1045)
Inverness, Florida, United States
RECRUITINGResearch Associates of South Florida - Miami - Southwest 8th Street ( Site 1072)
Miami, Florida, United States
RECRUITINGGastroenterology Associates of Central Georgia ( Site 1060)
Macon, Georgia, United States
RECRUITINGUniversity of Kansas Medical Center ( Site 1077)
Kansas City, Kansas, United States
RECRUITINGTulane University School of Medicine ( Site 1073)
New Orleans, Louisiana, United States
RECRUITINGBVL Research - Kansas ( Site 1054)
Liberty, Missouri, United States
RECRUITINGPercentage of Participants Achieving Clinical Response Per MMS at Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more from baseline, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Time frame: Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Endoscopic improvement is defined as ES of 0 or 1 with no friability. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant) and RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of less than or equal to 1.
Time frame: Week 12
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1 with no friability. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Time frame: Week 12