Psoriasis
Conditions
Brief summary
The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.
Interventions
Ruxolitinib phosphate cream 0.5%
DRUGDovonex® calcipotriene 0.005%
Cream applied once or twice daily for up to 56 days.
DRUGDiprolene® AF betamethasone dipropionate 0.05% cream.
Cream applied once or twice daily for up to 56 days
DRUGPlacebo cream
Cream applied once or twice daily for 56 days
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) of 17 to 40 kg/m2 * Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2 and these target lesions must be similar in size to each other, and separated by at least 15 cm.
Exclusion criteria
* Subjects with lesions solely involving the palms of the hands or soles of the feet or intertriginous areas, the scalp or the face. * Subjects with pustular psoriasis or erythroderma. * Subjects currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication. * Subjects receiving PUVA within 4 weeks of the first dose of study medication. * Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral immunosuppressives within 3 months prior to the first dose of study medication. * Subjects receiving any other biological therapy (infliximab, alefacept, abatacept, etc) within 3 months of the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Baseline, Days 8, 15, 22, 28 and 56 | The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). |
| Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Baseline, Days 8, 15, 22, 28 and 56 | The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe). |
| Number of Participants With Treatment Emergent Adverse Events | 3 months | A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug. |
| Pharmacokinetics Parameter : Skin Flux of INCB018424 | Days 8, 15, 22, and 28 | The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant. |
| Pharmacokinetics Parameter : Bioavailability of INCB018424 | Days 8, 15, 22, and 28 | The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Target Lesion Area Compared to Baseline | Day 28 | Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 6 study centers in the United States from 08 May 2007 to 28 April 2008. This study is completed.
Pre-assignment details
A total of 29 participants with active but stable plaque psoriasis were enrolled in the 2 part dose escalation study; 27 participant completed the study. In Part 1, each participant treated 1 plaque with INCB018424 cream, and a matching plaque with vehicle cream. In Part 2, each participant treated 1 plaque with INCB018424 cream, and a matching plaque with a comparator drug cream.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days | 6 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream Ruxolitinib 1.0% cream vs. vehicle cream once a day for 28 days | 6 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days | 6 |
| Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days | 6 |
| Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days | 5 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Scheduling Conflict | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream | Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream | Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream | Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) | Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 42.2 Years STANDARD_DEVIATION 14.25 | 48.8 Years STANDARD_DEVIATION 10.25 | 55.8 Years STANDARD_DEVIATION 10.38 | 50.2 Years STANDARD_DEVIATION 21.13 | 46.2 Years STANDARD_DEVIATION 10.08 | 48.7 Years STANDARD_DEVIATION 13.79 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 26 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 27 Participants |
| Sex/Gender, Customized Female | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 9 Participants |
| Sex/Gender, Customized Male | 4 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 29 |
| other Total, other adverse events | 6 / 6 | 1 / 6 | 5 / 6 | 4 / 6 | 2 / 5 | 18 / 29 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 29 |
Outcome results
Primary
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Time frame: Baseline, Days 8, 15, 22, 28 and 56
Population: Intent-to-Treat (ITT) population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -0.8 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -0.6 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.2 Scores on a scale | Standard Deviation 1.1 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.45 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.5 Scores on a scale | Standard Deviation 1.05 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.7 Scores on a scale | Standard Deviation 1.03 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.6 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.7 Scores on a scale | Standard Deviation 1.03 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.6 Scores on a scale | Standard Deviation 0.89 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -0.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -0.2 Scores on a scale | Standard Deviation 0.45 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.71 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.7 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | 0.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | 0.3 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | 0.0 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -0.8 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | 0.0 Scores on a scale | Standard Deviation 0 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.3 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.7 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | 0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | 0.2 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.2 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -0.3 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -0.7 Scores on a scale | Standard Deviation 1.03 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.3 Scores on a scale | Standard Deviation 0.52 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -0.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -1.0 Scores on a scale | Standard Deviation 0 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -1.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.5 Scores on a scale | Standard Deviation 0.55 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -1.2 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -1.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.98 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -0.8 Scores on a scale | Standard Deviation 0.98 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -1.2 Scores on a scale | Standard Deviation 0.41 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.98 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.75 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.5 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -1.0 Scores on a scale | Standard Deviation 1 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.8 Scores on a scale | Standard Deviation 1.3 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -1.2 Scores on a scale | Standard Deviation 1.1 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.0 Scores on a scale | Standard Deviation 1 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -1.2 Scores on a scale | Standard Deviation 0.75 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.4 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.71 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.6 Scores on a scale | Standard Deviation 1.14 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.4 Scores on a scale | Standard Deviation 1.14 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.6 Scores on a scale | Standard Deviation 1.14 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.8 Scores on a scale | Standard Deviation 1.1 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.6 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.6 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.0 Scores on a scale | Standard Deviation 1 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.0 Scores on a scale | Standard Deviation 0 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -1.2 Scores on a scale | Standard Deviation 1.47 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.7 Scores on a scale | Standard Deviation 1.21 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -1.0 Scores on a scale | Standard Deviation 0.63 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -0.8 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.6 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.6 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -0.8 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -1.0 Scores on a scale | Standard Deviation 1 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.5 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | 0.0 Scores on a scale | Standard Deviation 0.71 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.6 Scores on a scale | Standard Deviation 1.14 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -1.0 Scores on a scale | Standard Deviation 0.82 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | 0.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.0 Scores on a scale | Standard Deviation 0.71 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -1.0 Scores on a scale | Standard Deviation 0.71 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.4 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.5 Scores on a scale | Standard Deviation 0.58 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Scaling | -1.0 Scores on a scale | Standard Deviation 0.71 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Scaling | -0.8 Scores on a scale | Standard Deviation 0.5 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Scaling | -1.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Thickness | -0.4 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Erythema | -1.2 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.96 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Erythema | -1.8 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Scaling | -0.4 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Thickness | -0.6 Scores on a scale | Standard Deviation 0.89 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 15 - Scaling | -1.2 Scores on a scale | Standard Deviation 0.45 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 8 - Erythema | -1.3 Scores on a scale | Standard Deviation 0.96 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Thickness | -0.8 Scores on a scale | Standard Deviation 0.84 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 56/ET - Erythema | -0.6 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 22 - Erythema | -1.6 Scores on a scale | Standard Deviation 0.55 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline | Day 28 - Thickness | -1.2 Scores on a scale | Standard Deviation 0.45 |
Primary
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Time frame: Baseline, Days 8, 15, 22, 28 and 56
Population: ITT population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -1.4 Score on Scale | Standard Deviation 1.95 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -1.2 Score on Scale | Standard Deviation 1.3 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -1.5 Score on Scale | Standard Deviation 1.87 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -1.3 Score on Scale | Standard Deviation 1.75 |
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -1.3 Score on Scale | Standard Deviation 1.97 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -1.3 Score on Scale | Standard Deviation 1.75 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -1.0 Score on Scale | Standard Deviation 1.41 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -1.3 Score on Scale | Standard Deviation 1.21 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -1.3 Score on Scale | Standard Deviation 1.21 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -2.2 Score on Scale | Standard Deviation 1.79 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -1.8 Score on Scale | Standard Deviation 0.98 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -1.0 Score on Scale | Standard Deviation 0.63 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | 0.5 Score on Scale | Standard Deviation 1.87 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -1.3 Score on Scale | Standard Deviation 2.07 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -2.2 Score on Scale | Standard Deviation 1.17 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -3.0 Score on Scale | Standard Deviation 2 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -2.0 Score on Scale | Standard Deviation 1.79 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | 0.5 Score on Scale | Standard Deviation 1.38 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -1.7 Score on Scale | Standard Deviation 1.37 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -3.8 Score on Scale | Standard Deviation 1.6 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -1.7 Score on Scale | Standard Deviation 2.07 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -1.7 Score on Scale | Standard Deviation 2.07 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -1.7 Score on Scale | Standard Deviation 2.25 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -2.2 Score on Scale | Standard Deviation 1.6 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -1.8 Score on Scale | Standard Deviation 2.23 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -3.7 Score on Scale | Standard Deviation 1.37 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -3.0 Score on Scale | Standard Deviation 1.26 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -2.0 Score on Scale | Standard Deviation 2.1 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -3.2 Score on Scale | Standard Deviation 1.72 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -3.5 Score on Scale | Standard Deviation 1.76 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -2.0 Score on Scale | Standard Deviation 2.55 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -3.4 Score on Scale | Standard Deviation 2.7 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -3.2 Score on Scale | Standard Deviation 1.6 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -3.6 Score on Scale | Standard Deviation 3.13 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -2.4 Score on Scale | Standard Deviation 2.7 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -2.6 Score on Scale | Standard Deviation 1.82 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -2.2 Score on Scale | Standard Deviation 1.79 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -2.2 Score on Scale | Standard Deviation 1.79 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -3.2 Score on Scale | Standard Deviation 1.3 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -3.0 Score on Scale | Standard Deviation 2.9 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -3.0 Score on Scale | Standard Deviation 1.58 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -2.3 Score on Scale | Standard Deviation 0.96 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | 0.0 Score on Scale | Standard Deviation 2 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -2.4 Score on Scale | Standard Deviation 2.07 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -3.2 Score on Scale | Standard Deviation 1.64 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 22 | -3.4 Score on Scale | Standard Deviation 1.67 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 8 | -2.8 Score on Scale | Standard Deviation 1.71 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 15 | -3.0 Score on Scale | Standard Deviation 1.87 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 28 | -4.2 Score on Scale | Standard Deviation 1.79 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline | Day 56/ET | -1.4 Score on Scale | Standard Deviation 1.67 |
Primary
Number of Participants With Treatment Emergent Adverse Events
A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Number of Participants With Treatment Emergent Adverse Events | 6 Participants |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Number of Participants With Treatment Emergent Adverse Events | 1 Participants |
| Part 1 Cohort B: Vehicle Cream | Number of Participants With Treatment Emergent Adverse Events | 5 Participants |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Number of Participants With Treatment Emergent Adverse Events | 4 Participants |
| Part 1 Cohort C: Vehicle Cream | Number of Participants With Treatment Emergent Adverse Events | 2 Participants |
Primary
Pharmacokinetics Parameter : Bioavailability of INCB018424
The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.
Time frame: Days 8, 15, 22, and 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Pharmacokinetics Parameter : Bioavailability of INCB018424 | 2.8 Percentage of dosage | Standard Deviation 3.2 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Pharmacokinetics Parameter : Bioavailability of INCB018424 | 3.0 Percentage of dosage | Standard Deviation 1.9 |
| Part 1 Cohort B: Vehicle Cream | Pharmacokinetics Parameter : Bioavailability of INCB018424 | 3.0 Percentage of dosage | Standard Deviation 1.9 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Pharmacokinetics Parameter : Bioavailability of INCB018424 | 2.7 Percentage of dosage | Standard Deviation 1.1 |
| Part 1 Cohort C: Vehicle Cream | Pharmacokinetics Parameter : Bioavailability of INCB018424 | 2.7 Percentage of dosage | Standard Deviation 2.3 |
Primary
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Time frame: Days 8, 15, 22, and 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 54.2 ng/cm^2/h | Standard Deviation 40.8 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 151 ng/cm^2/h | Standard Deviation 70 |
| Part 1 Cohort B: Vehicle Cream | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 422 ng/cm^2/h | Standard Deviation 200 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 363 ng/cm^2/h | Standard Deviation 215 |
| Part 1 Cohort C: Vehicle Cream | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 383 ng/cm^2/h | Standard Deviation 256 |
Secondary
Change in Target Lesion Area Compared to Baseline
Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort A: Vehicle Cream | Change in Target Lesion Area Compared to Baseline | 0.35 cm^2 | Standard Deviation 4.872 |
| Part 1 Cohort A: Ruxolitinib 0.5% Cream | Change in Target Lesion Area Compared to Baseline | 1.53 cm^2 | Standard Deviation 9.76 |
| Part 1 Cohort B: Vehicle Cream | Change in Target Lesion Area Compared to Baseline | 0.45 cm^2 | Standard Deviation 3.775 |
| Part 1 Cohort B: Ruxolitinib 1.0% Cream | Change in Target Lesion Area Compared to Baseline | -3.18 cm^2 | Standard Deviation 8.651 |
| Part 1 Cohort C: Vehicle Cream | Change in Target Lesion Area Compared to Baseline | -4.03 cm^2 | Standard Deviation 12.303 |
| Part 1 Cohort C: Ruxolitinib 1.5% Cream | Change in Target Lesion Area Compared to Baseline | -11.45 cm^2 | Standard Deviation 13.851 |
| Part 2 Cohort D: INCB18424 | Change in Target Lesion Area Compared to Baseline | -5.22 cm^2 | Standard Deviation 6.203 |
| Part 2 Cohort D: Calcipotriene (Dovonex®) | Change in Target Lesion Area Compared to Baseline | -2.54 cm^2 | Standard Deviation 6.778 |
| Part 2 Cohort E: INCB18424 | Change in Target Lesion Area Compared to Baseline | 1.53 cm^2 | Standard Deviation 1.624 |
| Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) | Change in Target Lesion Area Compared to Baseline | -0.48 cm^2 | Standard Deviation 5.892 |