Psoriasis, Skin Diseases
Conditions
Keywords
Psoriasis, Orismilast
Brief summary
This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.
Interventions
Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
DRUGPlacebo
Matching placebo tablets
Sponsors
UNION therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
Intervention model description
Participants will be assigned randomly in a 1:1:1:1 ratio to receive 1 of the 3 orismilast modified release doses (20 mg, 30 mg, or 40 mg) or placebo twice daily (BID)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Capable of giving signed informed consent. 2. Male and female patients ≥18 years of age 3. Body weight of \>40 kg 4. Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable. 5. Moderate-to-severe plaque-type psoriasis as defined by Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (IGA) ≥3. 6. Candidate for systemic antipsoriatic treatment or phototherapy.
Exclusion criteria
1. Therapy-resistant psoriasis 2. Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit. 3. History of allergy or hypersensitivity to any component of the study treatment. 4. Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit. 5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 | Baseline and Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At Week 16 | 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). |
| 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 | At Weeks 4, 8, 12, and 20 | 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). |
| Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | At Weeks 4, 8, 12, and 20 | 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. |
| Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Baseline and Weeks 4, 8, 12, 16, and 20 | 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. |
| Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20 | At Weeks 4, 8, 12, 16, and 20 | 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. |
| Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | At Week 16 | 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. |
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Baseline and Weeks 16 and 20 | 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. |
| Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Baseline and Weeks 4, 8, 12, 16, and 20 | 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. |
| Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Baseline and Weeks 4, 8, 12, 16, and 20 | 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. |
| Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 | At Week 20 | 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. |
| Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Baseline and Weeks 4, 8, 12, and 20 | 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. |
Countries
Germany, Poland, United Kingdom, United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Tablets BID Oral, twice daily morning and evening for 16 weeks
Placebo: Matching placebo tablets | 51 |
| 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 PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation. | 48 |
| 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. | 50 |
| 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. | 53 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 10 | 11 | 21 |
| Overall Study | Lack of Efficacy | 8 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 3 | 1 |
| Overall Study | Other | 1 | 1 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo Tablets BID | Orismilast Modified Release Tablets 20 mg BID | Orismilast Modified Release Tablets 30 mg BID | Orismilast Modified Release Tablets 40 mg BID | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.10 years STANDARD_DEVIATION 11.98 | 45.40 years STANDARD_DEVIATION 13.87 | 48.20 years STANDARD_DEVIATION 13.4 | 44.30 years STANDARD_DEVIATION 14.6 | 45.70 years STANDARD_DEVIATION 13.48 |
| BMI | 29.420 kg/m^2 STANDARD_DEVIATION 6.271 | 31.019 kg/m^2 STANDARD_DEVIATION 8.548 | 30.464 kg/m^2 STANDARD_DEVIATION 5.963 | 29.000 kg/m^2 STANDARD_DEVIATION 5.921 | 29.948 kg/m^2 STANDARD_DEVIATION 6.727 |
| Disease duration | 19.30 years STANDARD_DEVIATION 11.33 | 22.00 years STANDARD_DEVIATION 14.21 | 18.10 years STANDARD_DEVIATION 11.99 | 19.80 years STANDARD_DEVIATION 13.69 | 19.80 years STANDARD_DEVIATION 12.83 |
| Disease duration > 2 years No | 2 Participants | 1 Participants | 3 Participants | 4 Participants | 10 Participants |
| Disease duration > 2 years Yes | 49 Participants | 47 Participants | 47 Participants | 49 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 48 Participants | 48 Participants | 52 Participants | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Females of Child-bearing potential No | 2 Participants | 4 Participants | 6 Participants | 5 Participants | 17 Participants |
| Females of Child-bearing potential Yes | 10 Participants | 13 Participants | 5 Participants | 10 Participants | 38 Participants |
| Height | 176.26 cm STANDARD_DEVIATION 8.67 | 174.14 cm STANDARD_DEVIATION 8.78 | 173.87 cm STANDARD_DEVIATION 9.3 | 176.90 cm STANDARD_DEVIATION 8.57 | 175.33 cm STANDARD_DEVIATION 8.86 |
| Psoriatic Arthritis No | 50 Participants | 46 Participants | 45 Participants | 47 Participants | 188 Participants |
| Psoriatic Arthritis Yes | 1 Participants | 2 Participants | 5 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 19 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 43 Participants | 46 Participants | 47 Participants | 180 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 11 Participants | 15 Participants | 55 Participants |
| Sex: Female, Male Male | 39 Participants | 31 Participants | 39 Participants | 38 Participants | 147 Participants |
| Weight | 91.48 kg STANDARD_DEVIATION 20.33 | 94.85 kg STANDARD_DEVIATION 29.96 | 91.65 kg STANDARD_DEVIATION 16.17 | 91.08 kg STANDARD_DEVIATION 21.17 | 92.22 kg STANDARD_DEVIATION 22.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 48 | 0 / 50 | 0 / 53 |
| other Total, other adverse events | 23 / 51 | 37 / 48 | 42 / 50 | 50 / 53 |
| serious Total, serious adverse events | 0 / 51 | 1 / 48 | 1 / 50 | 0 / 53 |
Outcome results
Primary
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16
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.
Time frame: Baseline and Week 16
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Tablets BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 | -17.30 percent change | Standard Error 7.07 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 | -52.60 percent change | Standard Error 6.8 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 | -61.20 percent change | Standard Error 6.67 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16 | -63.70 percent change | Standard Error 6.96 |
p-value: <0.00195% CI: [-54.7, -16]ANCOVA
p-value: <0.00195% CI: [-63.1, -24.8]ANCOVA
p-value: <0.00195% CI: [-65.6, -27.3]ANCOVA
Secondary
Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
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.
Time frame: At Weeks 4, 8, 12, 16, and 20
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 16 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 1 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 28 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 4 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 27 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 10 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 5 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 23 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 11 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 19 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 9 Participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 4 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 30 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 9 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 28 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 19 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 6 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 1 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 10 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 6 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 3 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 18 Participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 32 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 8 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 3 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 4 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 21 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 22 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 12 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 25 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 1 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 27 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 5 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 17 Participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 1 Participants |
Secondary
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16
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.
Time frame: At Week 16
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tablets BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | Yes | 16.5 percentage of participants |
| Placebo Tablets BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | No | 83.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | No | 60.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | Yes | 39.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | No | 51.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | Yes | 49.0 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | No | 53.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16 | Yes | 46.4 percentage of participants |
Secondary
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
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.
Time frame: At Weeks 4, 8, 12, and 20
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, No | 67.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, Yes | 31.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, Yes | 8.4 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, No | 91.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, Yes | 32.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, Yes | 42.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, No | 57.5 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, No | 68.4 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, Yes | 37.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, No | 50.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, Yes | 49.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, No | 78.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, Yes | 22.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, No | 89.2 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, No | 63.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, Yes | 10.8 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, No | 70.3 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, Yes | 31.2 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 8, No | 68.8 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, Yes | 38.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 12, No | 61.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 20, Yes | 29.7 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, Yes | 9.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20 | Week 4, No | 90.4 percentage of participants |
Secondary
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
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).
Time frame: At Week 16
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 73.8 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 26.2 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 75.5 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 24.5 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 20.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 79.4 percentage of participants |
Secondary
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
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).
Time frame: At Weeks 4, 8, 12, and 20
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 89.1 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 25.4 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 79.0 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 74.6 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 10.9 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 4.2 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 95.8 percentage of participants |
| Orismilast Modified Release Tablets 20 mg BID | 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 | 21.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 95.7 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 4.3 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 17.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 83.0 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 23.4 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 76.6 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 11.1 percentage of participants |
| Orismilast Modified Release Tablets 30 mg BID | 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 | 88.9 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 91.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 8.4 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 89.2 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 10.8 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 95.9 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 17.6 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 4.1 percentage of participants |
| Orismilast Modified Release Tablets 40 mg BID | 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 | 82.4 percentage of participants |
Secondary
Percentage of Participants Who Experienced Psoriasis Rebound by Week 20
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.
Time frame: At Week 20
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Tablets BID | Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 | 6 Participants |
| Orismilast Modified Release Tablets 20 mg BID | Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 | 2 Participants |
| Orismilast Modified Release Tablets 30 mg BID | Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 | 5 Participants |
| Orismilast Modified Release Tablets 40 mg BID | Percentage of Participants Who Experienced Psoriasis Rebound by Week 20 | 2 Participants |
Secondary
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tablets BID | 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 1.8 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -12.90 percent change | Standard Error 1.81 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -13.50 percent change | Standard Error 1.86 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -9.20 percent change | Standard Error 1.75 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -5.60 percent change | Standard Error 1.69 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -10.10 percent change | Standard Error 1.88 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -14.70 percent change | Standard Error 1.83 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -7.20 percent change | Standard Error 1.63 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -11.40 percent change | Standard Error 1.77 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -14.40 percent change | Standard Error 1.85 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -8.10 percent change | Standard Error 1.89 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -18.10 percent change | Standard Error 2.02 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -11.60 percent change | Standard Error 1.8 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -6.50 percent change | Standard Error 1.59 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -15.10 percent change | Standard Error 2 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -16.00 percent change | Standard Error 2.08 |
Secondary
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20
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.
Time frame: Baseline and Weeks 16 and 20
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 20 | -5.0 percent change | Standard Error 1.02 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 16 | -8.8 percent change | Standard Error 1.01 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 16 | -7.7 percent change | Standard Error 1 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 20 | -4.0 percent change | Standard Error 1.02 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 16 | -7.3 percent change | Standard Error 1.14 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20 | Week 20 | -4.9 percent change | Standard Error 1.17 |
Secondary
Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 16 | -1.4 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 8 | -1.1 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 20 mg BID | 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 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 16 | -1.0 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | 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 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 8 | -1.3 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 4 | -1.2 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 20 | -0.5 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 16 | -1.3 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 20 | -0.4 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 8 | -1.3 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 8 | -0.9 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 12 | -1.5 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 4 | -1.2 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 12 | -1.4 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 16 | -1.3 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 12 | -1.4 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 4 | -1.0 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 12 | -1.1 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 4 | -1.0 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 16 | -1.2 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 8 | -1.3 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 16 | -1.1 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 20 | -0.2 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 4 | -0.5 percent change | Standard Error 0.13 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 8 | -0.9 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 12 | -0.9 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 16 | -0.8 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 20 | -0.2 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 4 | -0.9 percent change | Standard Error 0.13 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 12 | -1.3 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 16 | -1.2 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 20 | -0.6 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 4 | -0.8 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 8 | -1.1 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 12 | -1.2 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 20 | -0.5 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 4 | -0.7 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 8 | -1.0 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 12 | -1.1 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 16 | -0.9 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 20 | -0.9 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 16 | -1.2 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 4 | -0.8 percent change | Standard Error 0.13 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 20 | -0.5 percent change | Standard Error 0.18 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 12 | -1.2 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | 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 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 16 | -0.9 percent change | Standard Error 0.18 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 4 | -0.7 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 16 | -0.7 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 8 | -1.2 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 8 | -1.2 percent change | Standard Error 0.16 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 12 | -0.9 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Pain, Week 8 | -1.0 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 20 | -0.4 percent change | Standard Error 0.18 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Burning, Week 12 | -1.1 percent change | Standard Error 0.18 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 12 | -1.1 percent change | Standard Error 0.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 8 | -1.2 percent change | Standard Error 0.15 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Itching, Week 4 | -0.9 percent change | Standard Error 0.14 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Redness, Week 4 | -0.9 percent change | Standard Error 0.13 |
Secondary
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
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.
Time frame: Baseline and Weeks 4, 8, 12, and 20
Population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 8 | -48.30 percent change | Standard Error 5.76 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 12 | -56.10 percent change | Standard Error 6.3 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 20 | -35.00 percent change | Standard Error 9.11 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 4 | -35.40 percent change | Standard Error 4.4 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 12 | -61.70 percent change | Standard Error 6.4 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 8 | -54.20 percent change | Standard Error 5.94 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 20 | -30.50 percent change | Standard Error 9.11 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 4 | -38.40 percent change | Standard Error 4.43 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 20 | -36.20 percent change | Standard Error 10.57 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 8 | -53.60 percent change | Standard Error 5.87 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 4 | -38.70 percent change | Standard Error 4.24 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20 | Week 12 | -57.50 percent change | Standard Error 6.59 |
Secondary
Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, and 20
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 |
| Placebo Tablets BID | 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 3.2 |
| Placebo Tablets BID | 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 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -2.9 percent change | Standard Deviation 4.71 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -4.6 percent change | Standard Deviation 3.38 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -6.2 percent change | Standard Deviation 3.79 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -5.7 percent change | Standard Deviation 4.25 |
| Orismilast Modified Release Tablets 20 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -4.9 percent change | Standard Deviation 3.61 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -2.2 percent change | Standard Deviation 4.84 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -5.2 percent change | Standard Deviation 4.28 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -4.8 percent change | Standard Deviation 4.32 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -3.2 percent change | Standard Deviation 3.77 |
| Orismilast Modified Release Tablets 30 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -5.2 percent change | Standard Deviation 4.17 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 4 | -3.8 percent change | Standard Deviation 3.8 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 8 | -5.4 percent change | Standard Deviation 3.91 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 16 | -5.1 percent change | Standard Deviation 3.48 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 20 | -3.1 percent change | Standard Deviation 3.73 |
| Orismilast Modified Release Tablets 40 mg BID | Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20 | Week 12 | -5.5 percent change | Standard Deviation 4.47 |