The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Participants will receive oral tablets of JNJ-67864238 twice daily.
Participants will receive oral tablets of matching placebo twice daily.
Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
CDAI is a validated measure of illness severity derived as sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s)/opiates, and general well-being). Last 3 variables were scored over 7 days by participant on diary card. Score ranges from 0 to 600; higher score=higher disease activities. Participants who had incomplete data (less than or equal to \[\<=\]4 component values missing) at the visit, had their last available component value carried forward to calculate CDAI Score. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy or adverse event of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to corona virus disease-19 related reasons had their CDAI data as missing.
Time frame: Baseline and Week 12
Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing \[strictures/ stenosis clinically\] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score= 0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score ranges=0 to 56, where higher scores=more severe disease. Participants who had prohibited change in concomitant CD medication, CD-related surgery or discontinued intervention due to lack of efficacy/AE of worsening CD prior to Week 12 had their baseline value carried forward. Participants who had discontinuation of intervention due to COVID-19 related reasons had their CDAI data as missing.
Time frame: Baseline and Week 12
Percentage of Participants With Clinical Response at Week 12
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Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Gastro Florida
Clearwater, Florida, United States
Gastroenterology Associates of Central GA
Macon, Georgia, United States
CroNOLA, LLC
Houma, Louisiana, United States
Washington University
St Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States
Columbia University Medical Center
New York, New York, United States
Northshore Gastroenterology Research, LLC
Beachwood, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
...and 53 more locations
Percentage of participants with clinical response at Week 12 were reported. Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in CDAI score or CDAI score less than (\<) 150. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Time frame: Week 12
Percentage of Participants With Clinical Remission at Week 12
Percentage of participants with clinical remission at Week 12 were reported. Clinical remission is defined as CDAI score \<150. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Time frame: Week 12
Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12
Percentage of participants with PRO-2 remission at Week 12 were reported. PRO-2 remission is defined as abdominal pain (AP) mean daily score (AP component of the CDAI) \<=1 and stool frequency (SF) mean daily score of \<=3, that is, AP \<=1 and SF \<=3. PRO-2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.
Time frame: Week 12
Percentage of Participants With Endoscopic Response at Week 12
Endoscopic response is defined as at least 50 percent (%) improvement from baseline in SES-CD score. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing \[strictures/ stenosis clinically\] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease.
Time frame: Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission defined as an SES-CD score of \<=2. SES-CD scoring system assesses disease severity in participants with CD. It is based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions and presence/type of narrowing \[strictures/ stenosis clinically\] across 5 predefined ileocolonic segments (ileum, right colon, transverse colon, left colon and rectum). Each component score=0 to 3 for each segment, total score calculated as sum of all component scores for all segments. Maximum sub-score for narrowings=11 points. Total SES-CD score range=0 to 56, where higher score=more severe disease.
Time frame: Week 12