Trial Outcomes & Findings for A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis (NCT NCT05223868)
NCT ID: NCT05223868
Last Updated: 2025-12-30
Results Overview
Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
Baseline (Week 0), Week 16
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Placebo
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
43
|
41
|
43
|
42
|
|
Overall Study
COMPLETED
|
36
|
36
|
40
|
40
|
41
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
3
|
1
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
3
|
1
|
1
|
2
|
|
Overall Study
Other
|
0
|
2
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 14.7 • n=174 Participants
|
44.5 Years
STANDARD_DEVIATION 12.72 • n=166 Participants
|
45.1 Years
STANDARD_DEVIATION 11.08 • n=167 Participants
|
45.7 Years
STANDARD_DEVIATION 11.91 • n=164 Participants
|
44.7 Years
STANDARD_DEVIATION 14.11 • n=671 Participants
|
42 Years
STANDARD_DEVIATION 11.34 • n=77 Participants
|
44.3 Years
STANDARD_DEVIATION 12.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=174 Participants
|
11 Participants
n=166 Participants
|
16 Participants
n=167 Participants
|
11 Participants
n=164 Participants
|
11 Participants
n=671 Participants
|
12 Participants
n=77 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=174 Participants
|
32 Participants
n=166 Participants
|
27 Participants
n=167 Participants
|
30 Participants
n=164 Participants
|
32 Participants
n=671 Participants
|
30 Participants
n=77 Participants
|
176 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
3 Participants
n=671 Participants
|
2 Participants
n=77 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=174 Participants
|
39 Participants
n=166 Participants
|
38 Participants
n=167 Participants
|
37 Participants
n=164 Participants
|
40 Participants
n=671 Participants
|
40 Participants
n=77 Participants
|
233 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=174 Participants
|
12 Participants
n=166 Participants
|
9 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
7 Participants
n=671 Participants
|
9 Participants
n=77 Participants
|
49 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
2 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
2 Participants
n=77 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=174 Participants
|
30 Participants
n=166 Participants
|
31 Participants
n=167 Participants
|
27 Participants
n=164 Participants
|
35 Participants
n=671 Participants
|
30 Participants
n=77 Participants
|
190 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
6 Participants
n=671 Participants
|
5 Participants
n=77 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=174 Participants
|
8 Participants
n=166 Participants
|
9 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
9 Participants
n=671 Participants
|
6 Participants
n=77 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
4 Participants
n=671 Participants
|
4 Participants
n=77 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, South
|
1 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
3 Participants
n=77 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=174 Participants
|
9 Participants
n=166 Participants
|
11 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
13 Participants
n=671 Participants
|
10 Participants
n=77 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
2 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
1 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
2 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
1 Participants
n=77 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=174 Participants
|
8 Participants
n=166 Participants
|
7 Participants
n=167 Participants
|
8 Participants
n=164 Participants
|
6 Participants
n=671 Participants
|
11 Participants
n=77 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 16Population: Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention.
Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16
|
9.3 Percentage of participants
|
37.2 Percentage of participants
|
58.1 Percentage of participants
|
51.2 Percentage of participants
|
65.1 Percentage of participants
|
78.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=37 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=39 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PASI Total Score at Week 16
|
-3.59 Units on a scale
Standard Deviation 9.436
|
-12.76 Units on a scale
Standard Deviation 8.050
|
-14.56 Units on a scale
Standard Deviation 6.528
|
-12.73 Units on a scale
Standard Deviation 8.021
|
-13.99 Units on a scale
Standard Deviation 8.653
|
-17.44 Units on a scale
Standard Deviation 8.356
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention.
Percentage of participants who achieved PASI-90 score (\>=90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16
|
2.3 Percentage of participants
|
25.6 Percentage of participants
|
51.2 Percentage of participants
|
26.8 Percentage of participants
|
46.5 Percentage of participants
|
59.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention.
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI-100) at Week 16
|
0 Percentage of participants
|
11.6 Percentage of participants
|
25.6 Percentage of participants
|
9.8 Percentage of participants
|
23.3 Percentage of participants
|
40.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
|
11.6 Percentages of participants
|
39.5 Percentages of participants
|
58.1 Percentages of participants
|
51.2 Percentages of participants
|
62.8 Percentages of participants
|
64.3 Percentages of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
|
0 Percentage of participants
|
16.3 Percentage of participants
|
34.9 Percentage of participants
|
14.6 Percentage of participants
|
27.9 Percentage of participants
|
45.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=37 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=39 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
|
-2.4 Percentage of BSA
Standard Deviation 16.51
|
-11.9 Percentage of BSA
Standard Deviation 10.00
|
-15.3 Percentage of BSA
Standard Deviation 11.41
|
-13.3 Percentage of BSA
Standard Deviation 11.08
|
-14.6 Percentage of BSA
Standard Deviation 14.03
|
-21.0 Percentage of BSA
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=37 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=39 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
|
-0.8 Units on a scale
Standard Deviation 29.59
|
-35.8 Units on a scale
Standard Deviation 29.22
|
-36.7 Units on a scale
Standard Deviation 29.95
|
-34.0 Units on a scale
Standard Deviation 29.19
|
-29.4 Units on a scale
Standard Deviation 28.28
|
-44.0 Units on a scale
Standard Deviation 31.22
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=37 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=39 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in PSSD Signs Score at Week 16
|
-6.2 Units on a scale
Standard Deviation 22.38
|
-38.6 Units on a scale
Standard Deviation 27.55
|
-42.7 Units on a scale
Standard Deviation 28.70
|
-41.8 Units on a scale
Standard Deviation 27.78
|
-41.9 Units on a scale
Standard Deviation 28.65
|
-51.1 Units on a scale
Standard Deviation 26.01
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: Analysis population included all randomized participants who received at least 1 administration of study intervention and had baseline PSSD symptom score \>=1.
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Participants With a Baseline Symptoms Score Greater Than or Equal to (>=) 1
|
0 Percentage of participants
|
16.3 Percentage of participants
|
23.8 Percentage of participants
|
17.1 Percentage of participants
|
27.9 Percentage of participants
|
26.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) , Week 16Population: Analysis population included all randomized participants who received at least 1 administration of study intervention and had baseline PSSD sign score \>=1.
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value was converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved PSSD Sign Score = 0 at Week 16 Among Participants With a Baseline Sign Score >=1
|
0 Percentage of participants
|
2.3 Percentage of participants
|
14.0 Percentage of participants
|
9.8 Percentage of participants
|
16.3 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: Analysis population included all randomized participants who received at least 1 administration of study intervention and had baseline DLQI score \>1.
The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a participant's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Participants With Baseline DLQI Score Greater Than (>) 1
|
2.4 Percentage of participants
|
27.9 Percentage of participants
|
37.2 Percentage of participants
|
30.0 Percentage of participants
|
55.8 Percentage of participants
|
43.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention. Here 'N' (overall number of participants analyzed) referred to the number of participants evaluable for this outcome measure.
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score= worst pain. Each domain included 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; standard deviation (SD) of 10 (T-Score). Higher PROMIS T-score=more of concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference, sleep disturbance= worse symptoms, higher scores in physical function, social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=37 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=40 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=39 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Physical Function
|
-1.04 Units on a scale
Standard Deviation 5.929
|
2.30 Units on a scale
Standard Deviation 6.060
|
5.81 Units on a scale
Standard Deviation 6.896
|
4.55 Units on a scale
Standard Deviation 7.789
|
3.10 Units on a scale
Standard Deviation 7.325
|
5.81 Units on a scale
Standard Deviation 8.408
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Anxiety
|
-2.36 Units on a scale
Standard Deviation 7.971
|
-3.98 Units on a scale
Standard Deviation 8.789
|
-5.27 Units on a scale
Standard Deviation 8.026
|
-5.27 Units on a scale
Standard Deviation 6.787
|
-4.70 Units on a scale
Standard Deviation 8.570
|
-8.31 Units on a scale
Standard Deviation 9.693
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Depression
|
-1.01 Units on a scale
Standard Deviation 6.238
|
-3.09 Units on a scale
Standard Deviation 8.709
|
-3.23 Units on a scale
Standard Deviation 6.576
|
-1.96 Units on a scale
Standard Deviation 6.569
|
-2.62 Units on a scale
Standard Deviation 7.465
|
-3.67 Units on a scale
Standard Deviation 8.912
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Fatigue
|
-0.76 Units on a scale
Standard Deviation 5.469
|
-2.44 Units on a scale
Standard Deviation 10.983
|
-1.50 Units on a scale
Standard Deviation 7.801
|
-3.09 Units on a scale
Standard Deviation 8.676
|
-2.98 Units on a scale
Standard Deviation 7.818
|
-3.75 Units on a scale
Standard Deviation 8.409
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Sleep Disturbance
|
0.14 Units on a scale
Standard Deviation 6.099
|
-1.89 Units on a scale
Standard Deviation 5.859
|
-3.45 Units on a scale
Standard Deviation 7.947
|
-4.36 Units on a scale
Standard Deviation 6.041
|
-1.04 Units on a scale
Standard Deviation 5.995
|
-3.19 Units on a scale
Standard Deviation 5.705
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Social Roles and Activities
|
0.99 Units on a scale
Standard Deviation 8.393
|
4.31 Units on a scale
Standard Deviation 9.035
|
4.82 Units on a scale
Standard Deviation 8.511
|
5.39 Units on a scale
Standard Deviation 10.908
|
5.78 Units on a scale
Standard Deviation 7.538
|
7.73 Units on a scale
Standard Deviation 9.607
|
|
Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
Pain Interference
|
0.09 Units on a scale
Standard Deviation 7.819
|
-6.79 Units on a scale
Standard Deviation 9.038
|
-7.41 Units on a scale
Standard Deviation 9.867
|
-7.18 Units on a scale
Standard Deviation 7.956
|
-3.98 Units on a scale
Standard Deviation 7.889
|
-9.56 Units on a scale
Standard Deviation 8.668
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 16Population: FAS included all randomized participants who received at least 1 administration of study intervention.
PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; ability to participate in social roles and activities) with 4 questions and pain intensity. Questions ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Higher score=worst pain. Each domain includes 4 items, plus a single pain intensity item totaling 29 items. Raw score of each PROMIS domain was converted into a standardized score with mean of 50; SD of 10 (T-Score). Higher PROMIS T-score= more of the concept being measured i.e. higher scores in anxiety, depression, fatigue, pain interference and sleep disturbance) indicated worse symptoms, higher scores in physical function and social roles= better functioning. Baseline: closest measurement taken prior to/at the time of first study drug administration date.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Physical Function
|
11.6 Percentage of participants
|
23.3 Percentage of participants
|
41.9 Percentage of participants
|
36.6 Percentage of participants
|
37.2 Percentage of participants
|
40.5 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Anxiety
|
30.2 Percentage of participants
|
32.6 Percentage of participants
|
44.2 Percentage of participants
|
53.7 Percentage of participants
|
41.9 Percentage of participants
|
54.8 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Depression
|
23.3 Percentage of participants
|
27.9 Percentage of participants
|
34.9 Percentage of participants
|
26.8 Percentage of participants
|
32.6 Percentage of participants
|
35.7 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Fatigue
|
18.6 Percentage of participants
|
20.9 Percentage of participants
|
23.3 Percentage of participants
|
41.5 Percentage of participants
|
25.6 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Sleep Disturbance
|
16.3 Percentage of participants
|
23.3 Percentage of participants
|
32.6 Percentage of participants
|
43.9 Percentage of participants
|
23.3 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Social Roles and Activities
|
23.3 Percentage of participants
|
30.2 Percentage of participants
|
46.5 Percentage of participants
|
56.1 Percentage of participants
|
44.2 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
Pain Interference
|
20.9 Percentage of participants
|
46.5 Percentage of participants
|
55.8 Percentage of participants
|
51.2 Percentage of participants
|
41.9 Percentage of participants
|
64.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 0 through Week 20Population: The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any event that occurred at or after the initial administration of study agent.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 Participants
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
22 Participants
|
20 Participants
|
26 Participants
|
20 Participants
|
19 Participants
|
26 Participants
|
|
Number of Participants With Treatment-emergent Adverse Event (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
JNJ-77242113 25 mg QD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
JNJ-77242113 50 mg QD
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
JNJ-77242113 25 mg BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
JNJ-77242113 100 mg QD
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
JNJ-77242113 100 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JNJ-77242113 25 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
Placebo
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
Other adverse events
| Measure |
JNJ-77242113 25 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
Placebo
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ- 77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in long-term extension (LTE) study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 50 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2\*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 25 mg BID
n=41 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg QD
n=43 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
JNJ-77242113 100 mg BID
n=42 participants at risk
Participants with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. At Week 16 participants had the option to enroll in LTE study 77242113PSO2002 (NCT05364554). Participants who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug at Week 16.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
9.3%
4/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
4.9%
2/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.4%
1/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Infections and infestations
Covid-19
|
11.6%
5/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
11.6%
5/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
7.0%
3/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
19.5%
8/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
4.7%
2/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
9.5%
4/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
4.7%
2/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
18.6%
8/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
7.3%
3/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
4.8%
2/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.0%
3/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
4.8%
2/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.4%
1/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
7.0%
3/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.4%
1/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.3%
1/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
0.00%
0/41 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
7.0%
3/43 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
2.4%
1/42 • From Week 0 through Week 20
The safety analyses set included all randomized participants who received at least 1 administration of study intervention.
|
Additional Information
Global Medical Head Dermatology
Janssen Research and Development, LLC
Phone: 844-434-4210
Email: [email protected]
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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER