Trial Outcomes & Findings for A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (NCT NCT04102111)
NCT ID: NCT04102111
Last Updated: 2025-02-04
Results Overview
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.
TERMINATED
PHASE2
48 participants
Baseline and Week 12
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
30
|
|
Overall Study
COMPLETED
|
14
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
1
|
3
|
Baseline Characteristics
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 13.49 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
ITALY
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=23 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
|
-153.2 units on a scale
Standard Deviation 94.71
|
-124.6 units on a scale
Standard Deviation 124.94
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=22 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
|
-0.4 units on a scale
Standard Deviation 2.27
|
-1.6 units on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Response at Week 12
|
61.1 percentage of participants
|
46.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 12
|
44.4 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Patient-reported Outcome (PRO)-2 Remission at Week 12
|
33.3 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Response at Week 12
|
5.6 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 Participants
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 12
|
5.6 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
Placebo
JNJ-67864238
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 participants at risk
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's Disease
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
6.7%
2/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Covid-19
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
6.7%
2/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Participants were randomized to receive matching placebo tablets orally twice daily for 12 weeks.
|
JNJ-67864238
n=30 participants at risk
Participants were randomized to receive JNJ-67864238 300 milligrams (mg) tablets orally twice daily for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Investigations
Lymphocyte Count Decreased
|
11.1%
2/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Blood and lymphatic system disorders
Basophilia
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Crohn's Disease
|
11.1%
2/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Mouth Swelling
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
6.7%
2/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Oral Disorder
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
General disorders
Asthenia
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
General disorders
Fatigue
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
General disorders
Pyrexia
|
11.1%
2/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Hepatobiliary disorders
Hepatic Cyst
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Covid-19
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Pyoderma
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Metabolism and nutrition disorders
Hypoferritinaemia
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Liver
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Nervous system disorders
Dizziness Exertional
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
13.3%
4/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Nervous system disorders
Sciatica
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Swelling
|
0.00%
0/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
3.3%
1/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
0.00%
0/30 • Up to 12 weeks for serious and other (non-serious) adverse events and up to 16 weeks for all-cause mortality
The safety analysis set included all randomized participants who received at least 1 dose of study intervention (placebo or JNJ-67864238).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER