Psoriasis
Conditions
Brief summary
The study objectives are the following: 1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of moderate-to-severe chronic plaque-type psoriasis. 2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis. 3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.
Detailed description
Study Design : This is a , multi-center, double blind, placebo-controlled, phase 2 (dose-finding) efficacy and safety study in which subjects with moderate-to- severe chronic plaque-type psoriasis will be randomized in a 1:1:1:1 allocation ratio to 1 of 3 active doses of XP23829 or placebo. Approximately 50 subjects will be enrolled into each treatment group. Study Periods: The study includes a 4-week screening phase, a 12-week treatment phase (with 9 weeks of XP23829 or placebo at the maintenance dose), and a 4-week observational post-treatment follow-up phase. A treatment-free follow-up period is designed to evaluate safety and disease relapse and rebound. Specifically, the study periods are as follows: 1. Screening Phase: Weeks -4 through 0 2. Treatment phase included: 1. Titration Phase: Weeks 1 through 3 2. Double-Blind Maintenance Phase: Weeks 4 through 12 3. Post-treatment follow-up: Weeks 13 through 16 Efficacy assessments will be performed in the clinic at Baseline (Visit 2) and at the end of Weeks 2, 4, 8, 12, 14, and 16. Patient-reported outcome measures will be assessed in the clinic at Baseline and at Week 12. Blood samples for pharmacodynamic (PD) assessments will be collected at Baseline and at Weeks 4, 8, 12 and 16. PD assessments will be conducted in all subjects, with the intent of evaluating psoriasis-associated inflammatory markers.
Interventions
DRUGXP23829 400 mg QD
active dose 1
DRUGXP 23829 800 mg QD
active dose 2
DRUGXP23829 400 mg BID
active dose 3
DRUGPlacebo
control
Sponsors
XenoPort, Inc.
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects, age ≥ 18. 2. Stable, moderate-to-severe plaque-type psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator). 3. Severity of disease meeting all of the following three criteria prior to randomization: 1. Psoriasis Area and Severity Index (PASI) score of 12 or greater 2. Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater 3. Static Physician's Global Assessment (sPGA) score of 3 or greater 4. Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
Exclusion criteria
1. Subjects with current inverse, erythrodermic, predominantly guttate, or pustular psoriasis. 2. Subjects with current drug-induced or drug-exacerbated psoriasis. 3. Subjects with moderate-to-severe psoriatic arthritis of any type; and subjects with mild psoriatic arthritis, who require systemic disease-modifying therapy. 4. Subjects with unstable or significant illness, including the presence of laboratory abnormalities at screening that in the opinion of the investigator would place the subject at unacceptable risk if he/she were to participate in the study. 5. Any skin condition (e.g. eczema) which confounds the ability to interpret data from the study. 6. Treatment with a topical anti-psoriatic therapy within 14 days prior to randomization (including topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin). 7. Phototherapy or prolonged sun exposure or use of ultraviolet (UV) light sources within 28 days of randomization. 8. Use of investigational or approved biologic treatments that are known to affect psoriasis, such as adalimumab, etanercept, golimumab or infliximab within 12 weeks of randomization and ustekinumab within 24 weeks of randomization. 9. Use of systemic medications (non-biologics) that are known to affect psoriasis (including but not limited to oral corticosteroids, cyclosporine, methotrexate, lithium, and beta-adrenergic blockers) within 4 weeks of randomization, or 5 half-lives, whichever is longer. 10. Prior treatment with Dimethyl Fumarate (Fumaderm® or Tecfidera®) or any other Fumaric Acid Ester (FAE) containing products. 11. Have failed (due to inadequate response) more than 3 approved systemic agents for the treatment of psoriasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline | 12 Weeks | The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Weeks 2, 4, 8, 12, 14 and 16 | The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index score (PASI-75) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject. |
| • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Weeks 2, 4, 8, 12, 14 and 16 | The Percentage of subjects who achieve the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. Score Grade : Definition - 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XP23829 400 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period
XP23829 400 mg QD: active dose 1 | 49 |
| XP23829 800 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period
XP 23829 800 mg QD: active dose 2 | 55 |
| XP23829 400 mg BID (Twice Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period
XP23829 400 mg BID: active dose 3 | 48 |
| Placebo After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks
Placebo: control | 48 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 8 | 13 | 5 |
| Overall Study | Lost to Follow-up | 4 | 4 | 2 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Subject unable to return for week 16 assessment within Sponsor timelines for study completion | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 10 | 4 | 8 |
Baseline characteristics
| Characteristic | XP23829 800 mg QD (Once Daily) | XP23829 400 mg QD (Once Daily) | Total | Placebo | XP23829 400 mg BID (Twice Daily) |
|---|---|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 10.55 | 50.8 years STANDARD_DEVIATION 11.89 | 50.3 years STANDARD_DEVIATION 12.49 | 51.1 years STANDARD_DEVIATION 13.66 | 51.8 years STANDARD_DEVIATION 13.8 |
| Baseline Body Surface Area involved | 23.79 percentage STANDARD_DEVIATION 15.283 | 22.90 percentage STANDARD_DEVIATION 13.324 | 24.04 percentage STANDARD_DEVIATION 14.86 | 26.44 percentage STANDARD_DEVIATION 16.26 | 23.08 percentage STANDARD_DEVIATION 14.585 |
| Baseline PASI score | 18.19 units on a scale STANDARD_DEVIATION 7.977 | 18.32 units on a scale STANDARD_DEVIATION 7.413 | 18.28 units on a scale STANDARD_DEVIATION 7.082 | 19.13 units on a scale STANDARD_DEVIATION 7.671 | 17.51 units on a scale STANDARD_DEVIATION 4.791 |
| Baseline sPGA 3 Moderate | 39 Participants | 32 Participants | 139 Participants | 34 Participants | 34 Participants |
| Baseline sPGA 4 Severe | 16 Participants | 17 Participants | 61 Participants | 14 Participants | 14 Participants |
| Body Weight | 101.68 kilograms STANDARD_DEVIATION 26.142 | 95.22 kilograms STANDARD_DEVIATION 25.71 | 98.85 kilograms STANDARD_DEVIATION 26.007 | 97.08 kilograms STANDARD_DEVIATION 25.136 | 101.08 kilograms STANDARD_DEVIATION 27.207 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 12 Participants | 31 Participants | 1 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 37 Participants | 169 Participants | 47 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Has Used Systemic Biologics? No | 34 Participants | 32 Participants | 131 Participants | 35 Participants | 30 Participants |
| Has Used Systemic Biologics? Yes | 21 Participants | 17 Participants | 69 Participants | 13 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 10 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 44 Participants | 181 Participants | 44 Participants | 45 Participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 70 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 32 Participants | 32 Participants | 130 Participants | 34 Participants | 32 Participants |
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 / 49 | 0 / 55 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 36 / 49 | 42 / 55 | 37 / 48 | 29 / 48 |
| serious Total, serious adverse events | 1 / 49 | 1 / 55 | 1 / 48 | 0 / 48 |
Outcome results
Primary
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Time frame: 12 Weeks
Population: modified Intent-to-Treat population Observed cases analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| XP23829 400 mg QD (Once Daily) | • The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline | -38.1 percentage change from baseline | Standard Error 5.07 |
| XP23829 800 mg QD (Once Daily) | • The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline | -48.2 percentage change from baseline | Standard Error 5.06 |
| XP23829 400 mg BID (Twice Daily) | • The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline | -50.7 percentage change from baseline | Standard Error 5.5 |
| Placebo | • The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline | -25.0 percentage change from baseline | Standard Error 5.06 |
p-value: 0.066Mixed Models Analysis
p-value: 0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index score (PASI-75) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
Time frame: Weeks 2, 4, 8, 12, 14 and 16
Population: modified Intent-to-treat population with last observation carried forward imputation for missing values
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 2 | 1 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 4 | 2 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 8 | 3 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 12 | 6 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 14 | 6 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 16 | 3 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 16 | 3 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 12 | 7 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 2 | 0 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 8 | 2 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 4 | 0 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 14 | 4 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 4 | 2 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 8 | 5 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 12 | 10 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 16 | 6 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 14 | 6 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 2 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 14 | 3 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 16 | 2 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 4 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 12 | 4 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 2 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) | Week 8 | 2 Participants |
Comparison: Week 12 comparisonp-value: 0.501Regression, Logistic
Comparison: Week 12 comparisonp-value: 0.34Regression, Logistic
Comparison: Week 12 comparisonp-value: 0.075Regression, Logistic
Secondary
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear
The Percentage of subjects who achieve the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. Score Grade : Definition - 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.
Time frame: Weeks 2, 4, 8, 12, 14 and 16
Population: modified 'Intent-to-treat' population using Last Observation Carried Forward method to impute missing observations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 2 | 0 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 4 | 1 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 8 | 2 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 12 | 5 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 14 | 5 Participants |
| XP23829 400 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 16 | 5 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 16 | 1 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 12 | 3 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 2 | 0 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 8 | 2 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 4 | 1 Participants |
| XP23829 800 mg QD (Once Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 14 | 2 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 4 | 0 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 8 | 1 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 12 | 3 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 16 | 4 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 14 | 3 Participants |
| XP23829 400 mg BID (Twice Daily) | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 2 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 14 | 1 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 16 | 1 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 4 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 12 | 2 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 2 | 0 Participants |
| Placebo | • Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear | Week 8 | 2 Participants |
Comparison: Week 12 comparisonp-value: 0.229Regression, Logistic
Comparison: Week 12 comparisonp-value: 0.604Regression, Logistic
Comparison: Week 12 comparisonp-value: 0.573Regression, Logistic