A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

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

Population: Full analysis set (FAS) included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure (OM).

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Here, 'N' (Number of participants analyzed) included all participants evaluable for this outcome measure.

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, were not considered to be in clinical remission.

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, were not considered to be in clinical response.

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be in endoscopic remission.

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be in endoscopic response.

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

Population: FAS included participants who were randomized to either JNJ-67864238 or placebo and received at least 1 dose of study intervention. Participants who met 1 or more treatment failure rules: had prohibited change in concomitant CD medication, had CD-related surgery, discontinued intervention due to lack of efficacy or AE of worsening CD prior to Week 12 or discontinuation of intervention due to COVID-19 related reasons, are not considered to be PRO-2 remission.