Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Orismilast in Psoriasis (NCT NCT05190419)
NCT ID: NCT05190419
Last Updated: 2024-04-16
Results Overview
The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2024-04-16
Participant Flow
A total of 202 participants were randomized at 26 sites in Germany (8 sites), Poland (12 sites), the United Kingdom (1 site), and the US (5 sites).
Participant milestones
| Measure |
Placebo Tablets BID
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
48
|
50
|
53
|
|
Overall Study
COMPLETED
|
32
|
34
|
33
|
26
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
17
|
27
|
Reasons for withdrawal
| Measure |
Placebo Tablets BID
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
8
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
2
|
10
|
11
|
21
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
1
|
|
Overall Study
Other
|
1
|
1
|
0
|
3
|
Baseline Characteristics
Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
Baseline characteristics by cohort
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.10 years
STANDARD_DEVIATION 11.98 • n=51 Participants
|
45.40 years
STANDARD_DEVIATION 13.87 • n=48 Participants
|
48.20 years
STANDARD_DEVIATION 13.40 • n=50 Participants
|
44.30 years
STANDARD_DEVIATION 14.60 • n=53 Participants
|
45.70 years
STANDARD_DEVIATION 13.48 • n=202 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=51 Participants
|
17 Participants
n=48 Participants
|
11 Participants
n=50 Participants
|
15 Participants
n=53 Participants
|
55 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=51 Participants
|
31 Participants
n=48 Participants
|
39 Participants
n=50 Participants
|
38 Participants
n=53 Participants
|
147 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=53 Participants
|
5 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=51 Participants
|
48 Participants
n=48 Participants
|
48 Participants
n=50 Participants
|
52 Participants
n=53 Participants
|
197 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=51 Participants
|
43 Participants
n=48 Participants
|
46 Participants
n=50 Participants
|
47 Participants
n=53 Participants
|
180 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=53 Participants
|
1 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=53 Participants
|
2 Participants
n=202 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
5 Participants
n=51 Participants
|
5 Participants
n=48 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=53 Participants
|
19 Participants
n=202 Participants
|
|
Psoriatic Arthritis
Yes
|
1 Participants
n=51 Participants
|
2 Participants
n=48 Participants
|
5 Participants
n=50 Participants
|
6 Participants
n=53 Participants
|
14 Participants
n=202 Participants
|
|
Psoriatic Arthritis
No
|
50 Participants
n=51 Participants
|
46 Participants
n=48 Participants
|
45 Participants
n=50 Participants
|
47 Participants
n=53 Participants
|
188 Participants
n=202 Participants
|
|
Disease duration
|
19.30 years
STANDARD_DEVIATION 11.33 • n=51 Participants
|
22.00 years
STANDARD_DEVIATION 14.21 • n=48 Participants
|
18.10 years
STANDARD_DEVIATION 11.99 • n=50 Participants
|
19.80 years
STANDARD_DEVIATION 13.69 • n=53 Participants
|
19.80 years
STANDARD_DEVIATION 12.83 • n=202 Participants
|
|
Disease duration > 2 years
Yes
|
49 Participants
n=51 Participants
|
47 Participants
n=48 Participants
|
47 Participants
n=50 Participants
|
49 Participants
n=53 Participants
|
192 Participants
n=202 Participants
|
|
Disease duration > 2 years
No
|
2 Participants
n=51 Participants
|
1 Participants
n=48 Participants
|
3 Participants
n=50 Participants
|
4 Participants
n=53 Participants
|
10 Participants
n=202 Participants
|
|
Height
|
176.26 cm
STANDARD_DEVIATION 8.67 • n=51 Participants
|
174.14 cm
STANDARD_DEVIATION 8.78 • n=48 Participants
|
173.87 cm
STANDARD_DEVIATION 9.30 • n=50 Participants
|
176.90 cm
STANDARD_DEVIATION 8.57 • n=53 Participants
|
175.33 cm
STANDARD_DEVIATION 8.86 • n=202 Participants
|
|
Weight
|
91.48 kg
STANDARD_DEVIATION 20.33 • n=51 Participants
|
94.85 kg
STANDARD_DEVIATION 29.96 • n=48 Participants
|
91.65 kg
STANDARD_DEVIATION 16.17 • n=50 Participants
|
91.08 kg
STANDARD_DEVIATION 21.17 • n=53 Participants
|
92.22 kg
STANDARD_DEVIATION 22.24 • n=202 Participants
|
|
BMI
|
29.420 kg/m^2
STANDARD_DEVIATION 6.271 • n=51 Participants
|
31.019 kg/m^2
STANDARD_DEVIATION 8.548 • n=48 Participants
|
30.464 kg/m^2
STANDARD_DEVIATION 5.963 • n=50 Participants
|
29.000 kg/m^2
STANDARD_DEVIATION 5.921 • n=53 Participants
|
29.948 kg/m^2
STANDARD_DEVIATION 6.727 • n=202 Participants
|
|
Females of Child-bearing potential
Yes
|
10 Participants
n=12 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
13 Participants
n=17 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
5 Participants
n=11 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
10 Participants
n=15 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
38 Participants
n=55 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
|
Females of Child-bearing potential
No
|
2 Participants
n=12 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
4 Participants
n=17 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
6 Participants
n=11 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
5 Participants
n=15 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
17 Participants
n=55 Participants • Number of participants analyzed includes the total number of females of child-bearing potential in each arm.
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16
|
-17.30 percent change
Standard Error 7.07
|
-52.60 percent change
Standard Error 6.80
|
-61.20 percent change
Standard Error 6.67
|
-63.70 percent change
Standard Error 6.96
|
SECONDARY outcome
Timeframe: At Week 16Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16
Yes
|
16.5 percentage of participants
|
39.5 percentage of participants
|
49.0 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16
No
|
83.5 percentage of participants
|
60.5 percentage of participants
|
51.0 percentage of participants
|
53.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient's psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Week 16
Yes
|
6.9 percentage of participants
|
26.2 percentage of participants
|
24.5 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Week 16
No
|
93.1 percentage of participants
|
73.8 percentage of participants
|
75.5 percentage of participants
|
79.4 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient's psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 4, Yes
|
2.1 percentage of participants
|
4.2 percentage of participants
|
4.3 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 4, No
|
97.9 percentage of participants
|
95.8 percentage of participants
|
95.7 percentage of participants
|
95.9 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 8, Yes
|
0 percentage of participants
|
10.9 percentage of participants
|
17.0 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 8, No
|
100 percentage of participants
|
89.1 percentage of participants
|
83.0 percentage of participants
|
91.6 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 12, Yes
|
4.6 percentage of participants
|
25.4 percentage of participants
|
23.4 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 12, No
|
95.4 percentage of participants
|
74.6 percentage of participants
|
76.6 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 20, Yes
|
11.3 percentage of participants
|
21.0 percentage of participants
|
11.1 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
Week 20, No
|
88.7 percentage of participants
|
79.0 percentage of participants
|
88.9 percentage of participants
|
89.2 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 4, Yes
|
6.0 percentage of participants
|
8.4 percentage of participants
|
10.8 percentage of participants
|
9.6 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 4, No
|
94.0 percentage of participants
|
91.6 percentage of participants
|
89.2 percentage of participants
|
90.4 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 8, Yes
|
11.8 percentage of participants
|
32.5 percentage of participants
|
37.0 percentage of participants
|
31.2 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 8, No
|
88.2 percentage of participants
|
67.5 percentage of participants
|
63.0 percentage of participants
|
68.8 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 12, Yes
|
12.3 percentage of participants
|
42.5 percentage of participants
|
49.5 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 12, No
|
87.7 percentage of participants
|
57.5 percentage of participants
|
50.5 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 20, Yes
|
18.7 percentage of participants
|
31.6 percentage of participants
|
22.0 percentage of participants
|
29.7 percentage of participants
|
|
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
Week 20, No
|
81.3 percentage of participants
|
68.4 percentage of participants
|
78.0 percentage of participants
|
70.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12, 16, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI 50, 90, and 100 is 50%, 90%, and 100% reduction from Baseline in PASI score, respectively.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 8, PASI 50
|
11 Participants
|
28 Participants
|
28 Participants
|
27 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 8, PASI 90
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 8, PASI 100
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 12, PASI 50
|
15 Participants
|
27 Participants
|
32 Participants
|
22 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 12, PASI 90
|
3 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 12, PASI 100
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 16, PASI 50
|
13 Participants
|
23 Participants
|
30 Participants
|
25 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 16, PASI 90
|
4 Participants
|
11 Participants
|
10 Participants
|
12 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 16, PASI 100
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 20, PASI 50
|
12 Participants
|
19 Participants
|
19 Participants
|
17 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 20, PASI 90
|
3 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 20, PASI 100
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 4, PASI 50
|
8 Participants
|
16 Participants
|
18 Participants
|
21 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 4, PASI 90
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
Week 4, PASI 100
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
Week 4
|
-14.40 percent change
Standard Error 4.33
|
-35.40 percent change
Standard Error 4.40
|
-38.40 percent change
Standard Error 4.43
|
-38.70 percent change
Standard Error 4.24
|
|
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
Week 8
|
-16.10 percent change
Standard Error 5.79
|
-48.30 percent change
Standard Error 5.76
|
-54.20 percent change
Standard Error 5.94
|
-53.60 percent change
Standard Error 5.87
|
|
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
Week 12
|
-18.10 percent change
Standard Error 6.61
|
-56.10 percent change
Standard Error 6.30
|
-61.70 percent change
Standard Error 6.40
|
-57.50 percent change
Standard Error 6.59
|
|
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
Week 20
|
-13.70 percent change
Standard Error 9.69
|
-35.00 percent change
Standard Error 9.11
|
-30.50 percent change
Standard Error 9.11
|
-36.20 percent change
Standard Error 10.57
|
SECONDARY outcome
Timeframe: Baseline and Weeks 16 and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm.
The DLQI is a 10-item validated questionnaire completed by the patient used to assess the impact of skin disease on the patient's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much," respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.
Outcome measures
| Measure |
Placebo Tablets BID
n=34 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=34 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=35 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=27 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20
Week 16
|
-4.9 percent change
Standard Error 1.02
|
-8.8 percent change
Standard Error 1.01
|
-7.7 percent change
Standard Error 1.00
|
-7.3 percent change
Standard Error 1.14
|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20
Week 20
|
-5.1 percent change
Standard Error 1.06
|
-5.0 percent change
Standard Error 1.02
|
-4.0 percent change
Standard Error 1.02
|
-4.9 percent change
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.
The BSA assessment estimates the extent of disease or skin affected by psoriasis and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the patient palm = 1% BSA rule. The patient's palm is measured from the wrist to the proximal interphalangeal and thumb.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=46 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=52 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Week 4
|
-2.30 percent change
Standard Error 1.62
|
-5.60 percent change
Standard Error 1.69
|
-7.20 percent change
Standard Error 1.63
|
-6.50 percent change
Standard Error 1.59
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Week 8
|
-3.80 percent change
Standard Error 1.67
|
-9.20 percent change
Standard Error 1.75
|
-11.40 percent change
Standard Error 1.77
|
-11.60 percent change
Standard Error 1.80
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Week 12
|
-5.30 percent change
Standard Error 1.80
|
-12.90 percent change
Standard Error 1.81
|
-14.70 percent change
Standard Error 1.83
|
-15.10 percent change
Standard Error 2.00
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Week 16
|
-6.90 percent change
Standard Error 1.87
|
-13.50 percent change
Standard Error 1.86
|
-14.40 percent change
Standard Error 1.85
|
-18.10 percent change
Standard Error 2.02
|
|
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
Week 20
|
-6.20 percent change
Standard Error 1.96
|
-10.10 percent change
Standard Error 1.88
|
-8.10 percent change
Standard Error 1.89
|
-16.00 percent change
Standard Error 2.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.
The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.
Outcome measures
| Measure |
Placebo Tablets BID
n=49 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=45 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=46 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=49 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Week 4
|
-1.1 percent change
Standard Deviation 3.82
|
-4.6 percent change
Standard Deviation 3.38
|
-3.2 percent change
Standard Deviation 3.77
|
-3.8 percent change
Standard Deviation 3.80
|
|
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Week 8
|
-1.8 percent change
Standard Deviation 3.23
|
-4.9 percent change
Standard Deviation 3.61
|
-5.2 percent change
Standard Deviation 4.17
|
-5.4 percent change
Standard Deviation 3.91
|
|
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Week 12
|
-2.3 percent change
Standard Deviation 3.46
|
-6.2 percent change
Standard Deviation 3.79
|
-5.2 percent change
Standard Deviation 4.28
|
-5.5 percent change
Standard Deviation 4.47
|
|
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Week 16
|
-1.8 percent change
Standard Deviation 3.27
|
-5.7 percent change
Standard Deviation 4.25
|
-4.8 percent change
Standard Deviation 4.32
|
-5.1 percent change
Standard Deviation 3.48
|
|
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Week 20
|
-2.3 percent change
Standard Deviation 3.20
|
-2.9 percent change
Standard Deviation 4.71
|
-2.2 percent change
Standard Deviation 4.84
|
-3.1 percent change
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.
The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.
Outcome measures
| Measure |
Placebo Tablets BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=45 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=49 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Pain, Week 4
|
-0.6 percent change
Standard Error 0.13
|
-1.0 percent change
Standard Error 0.14
|
-0.5 percent change
Standard Error 0.13
|
-0.8 percent change
Standard Error 0.13
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Pain, Week 8
|
-0.6 percent change
Standard Error 0.14
|
-0.9 percent change
Standard Error 0.14
|
-0.9 percent change
Standard Error 0.14
|
-1.0 percent change
Standard Error 0.15
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Pain, Week 12
|
-0.6 percent change
Standard Error 0.15
|
-1.1 percent change
Standard Error 0.15
|
-0.9 percent change
Standard Error 0.15
|
-0.9 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Pain, Week 16
|
-0.4 percent change
Standard Error 0.15
|
-1.0 percent change
Standard Error 0.15
|
-0.8 percent change
Standard Error 0.15
|
-0.7 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Pain, Week 20
|
-0.5 percent change
Standard Error 0.16
|
-0.4 percent change
Standard Error 0.15
|
-0.2 percent change
Standard Error 0.15
|
-0.5 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Redness, Week 4
|
-0.3 percent change
Standard Error 0.13
|
-1.0 percent change
Standard Error 0.14
|
-0.9 percent change
Standard Error 0.13
|
-0.9 percent change
Standard Error 0.13
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Redness, Week 8
|
-0.6 percent change
Standard Error 0.14
|
-1.1 percent change
Standard Error 0.14
|
-1.3 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.15
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Redness, Week 12
|
-0.9 percent change
Standard Error 0.15
|
-1.5 percent change
Standard Error 0.15
|
-1.3 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Redness, Week 16
|
-0.6 percent change
Standard Error 0.15
|
-1.4 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Redness, Week 20
|
-0.7 percent change
Standard Error 0.16
|
-0.7 percent change
Standard Error 0.15
|
-0.6 percent change
Standard Error 0.15
|
-0.9 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Itching, Week 4
|
-0.4 percent change
Standard Error 0.14
|
-1.2 percent change
Standard Error 0.14
|
-0.8 percent change
Standard Error 0.14
|
-0.9 percent change
Standard Error 0.14
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Itching, Week 8
|
-0.6 percent change
Standard Error 0.14
|
-1.3 percent change
Standard Error 0.15
|
-1.1 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.15
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Itching, Week 12
|
-0.5 percent change
Standard Error 0.15
|
-1.4 percent change
Standard Error 0.16
|
-1.2 percent change
Standard Error 0.16
|
-1.1 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Itching, Week 16
|
-0.4 percent change
Standard Error 0.16
|
-1.3 percent change
Standard Error 0.16
|
-1.2 percent change
Standard Error 0.16
|
-0.9 percent change
Standard Error 0.17
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Itching, Week 20
|
-0.7 percent change
Standard Error 0.17
|
-0.5 percent change
Standard Error 0.16
|
-0.5 percent change
Standard Error 0.16
|
-0.5 percent change
Standard Error 0.18
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Burning, Week 4
|
-0.4 percent change
Standard Error 0.14
|
-1.2 percent change
Standard Error 0.15
|
-0.7 percent change
Standard Error 0.14
|
-0.7 percent change
Standard Error 0.14
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Burning, Week 8
|
-0.7 percent change
Standard Error 0.15
|
-1.3 percent change
Standard Error 0.15
|
-1.0 percent change
Standard Error 0.15
|
-1.2 percent change
Standard Error 0.16
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Burning, Week 12
|
-0.6 percent change
Standard Error 0.16
|
-1.4 percent change
Standard Error 0.16
|
-1.1 percent change
Standard Error 0.16
|
-1.1 percent change
Standard Error 0.18
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Burning, Week 16
|
-0.5 percent change
Standard Error 0.16
|
-1.3 percent change
Standard Error 0.16
|
-1.1 percent change
Standard Error 0.16
|
-0.9 percent change
Standard Error 0.18
|
|
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
Burning, Week 20
|
-0.5 percent change
Standard Error 0.17
|
-0.5 percent change
Standard Error 0.16
|
-0.2 percent change
Standard Error 0.16
|
-0.4 percent change
Standard Error 0.18
|
SECONDARY outcome
Timeframe: At Week 20Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
Outcome measures
| Measure |
Placebo Tablets BID
n=51 Participants
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 Participants
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced Psoriasis Rebound by Week 20
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
Placebo Tablets BID
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Orismilast Modified Release Tablets 20 mg BID
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Orismilast Modified Release Tablets 30 mg BID
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Orismilast Modified Release Tablets 40 mg BID
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Tablets BID
n=51 participants at risk
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Cardiac disorders
Transient ischaemic attack
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
Other adverse events
| Measure |
Placebo Tablets BID
n=51 participants at risk
Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets
|
Orismilast Modified Release Tablets 20 mg BID
n=48 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 30 mg BID
n=50 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
Orismilast Modified Release Tablets 40 mg BID
n=53 participants at risk
Oral, twice daily morning and evening for 16 weeks
Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
2/51 • Number of events 2 • 16 weeks
|
37.5%
18/48 • Number of events 24 • 16 weeks
|
48.0%
24/50 • Number of events 35 • 16 weeks
|
45.3%
24/53 • Number of events 43 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 2 • 16 weeks
|
22.9%
11/48 • Number of events 12 • 16 weeks
|
38.0%
19/50 • Number of events 23 • 16 weeks
|
41.5%
22/53 • Number of events 24 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
6.0%
3/50 • Number of events 3 • 16 weeks
|
11.3%
6/53 • Number of events 9 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 2 • 16 weeks
|
11.3%
6/53 • Number of events 8 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
8.3%
4/48 • Number of events 4 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
6.0%
3/50 • Number of events 3 • 16 weeks
|
1.9%
1/53 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
6.2%
3/48 • Number of events 3 • 16 weeks
|
8.0%
4/50 • Number of events 6 • 16 weeks
|
13.2%
7/53 • Number of events 19 • 16 weeks
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 6 • 16 weeks
|
12.5%
6/48 • Number of events 9 • 16 weeks
|
26.0%
13/50 • Number of events 16 • 16 weeks
|
20.8%
11/53 • Number of events 14 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • 16 weeks
|
6.2%
3/48 • Number of events 3 • 16 weeks
|
14.0%
7/50 • Number of events 8 • 16 weeks
|
15.1%
8/53 • Number of events 10 • 16 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
5.7%
3/53 • Number of events 3 • 16 weeks
|
|
Infections and infestations
COVID-19
|
5.9%
3/51 • Number of events 3 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
7.5%
4/53 • Number of events 4 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Number of events 3 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
8.0%
4/50 • Number of events 4 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
General disorders
Fatigue
|
2.0%
1/51 • Number of events 3 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
4.0%
2/50 • Number of events 2 • 16 weeks
|
5.7%
3/53 • Number of events 4 • 16 weeks
|
|
General disorders
Asthenia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
6.0%
3/50 • Number of events 5 • 16 weeks
|
3.8%
2/53 • Number of events 2 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.9%
3/51 • Number of events 4 • 16 weeks
|
6.2%
3/48 • Number of events 3 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
9.4%
5/53 • Number of events 5 • 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • 16 weeks
|
4.2%
2/48 • Number of events 2 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
3.8%
2/53 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
3.8%
2/53 • Number of events 3 • 16 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
3.8%
2/53 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Gastrointestinal disorders
Mucous stools
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Gastrointestinal disorders
Trichoglossia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Parosmia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Slow response to stimuli
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
4.0%
2/50 • Number of events 2 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Cystitis
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
4.0%
2/50 • Number of events 2 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Abscess limb
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Body tinea
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Gingivitis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Parotitis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
Discomfort
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
General disorders
Malaise
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
Chills
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
Illness
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
General disorders
Pain
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
General disorders
Pyrexia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
Electrocardiogram abnormal
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
2.1%
1/48 • Number of events 2 • 16 weeks
|
2.0%
1/50 • Number of events 2 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
3.8%
2/53 • Number of events 2 • 16 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
C-reactive protein increased
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Crystal urine present
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Haematocrit increased
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Mean cell volume increased
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Bacterial test positive
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
Blood triglycerides increased
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Neutrophil count abnormal
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Protein urine present
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Urinary sediment present
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Investigations
Blood glucose increased
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
High density lipoprotein decreased
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
Inflammatory marker increased
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
QRS axis abnormal
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Investigations
Ultrasound abdomen abnormal
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 2 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 2 • 16 weeks
|
3.8%
2/53 • Number of events 2 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
4.0%
2/50 • Number of events 2 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
1/51 • Number of events 2 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/51 • 16 weeks
|
4.2%
2/48 • Number of events 2 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
4.2%
2/48 • Number of events 3 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Depression
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
1.9%
1/53 • Number of events 1 • 16 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/51 • 16 weeks
|
2.1%
1/48 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
|
Renal and urinary disorders
Renal colic
|
2.0%
1/51 • Number of events 1 • 16 weeks
|
0.00%
0/48 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
0.00%
0/53 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place