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A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00820950
Collaborator
(none)
29
Enrollment
6
Locations
5
Arms
23
Actual Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ruxolitinib phosphate cream
  • Drug: Dovonex® calcipotriene 0.005%
  • Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
  • Drug: Placebo cream
  • Drug: Ruxolitinib phosphate cream
  • Drug: Ruxolitinib phosphate cream
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Actual Study Start Date :
May 31, 2007
Actual Primary Completion Date :
Jan 31, 2009
Actual Study Completion Date :
Apr 30, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A: INCB018424 Ruxolitinib 0.5%

INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days

Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream 0.5%
Other Names:
  • INCB018424

    • Drug: Placebo cream
    Cream applied once or twice daily for 56 days
    Experimental: Cohort B: INCB018424 Ruxolitinib 1.0%

    INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days

    Drug: Placebo cream
    Cream applied once or twice daily for 56 days

    Drug: Ruxolitinib phosphate cream
    Ruxolitinib phosphate cream 1.0%
    Other Names:
  • INCB018424

    		•
    Experimental: Cohort C: INCB018424 Ruxolitinib 1.5%

    INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

    Drug: Placebo cream
    Cream applied once or twice daily for 56 days

    Drug: Ruxolitinib phosphate cream
    Ruxolitinib phosphate cream 1.5%
    Other Names:
  • INCB018424

    		•
    Experimental: Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

    INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days

    Drug: Dovonex® calcipotriene 0.005%
    Cream applied once or twice daily for up to 56 days.
    Experimental: Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

    INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

    Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
    Cream applied once or twice daily for up to 56 days

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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.

    4. 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.

    5. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vallejo California United States
    2 Boston Massachusetts United States
    3 Rochester New York United States
    4 Stony Brook New York United States
    5 Portland Oregon United States
    6 Philadelphia Pennsylvania United States

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: William Williams, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT00820950
    Other Study ID Numbers:
    • INCB 18424-201
    First Posted:
    Jan 12, 2009
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Psoriasis
    Betamethasone
    Betamethasone Valerate
    Betamethasone-17,21-dipropionate
    Betamethasone benzoate
    Calcipotriene
    Betamethasone sodium phosphate

    Study Results

    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 Detail 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.
    Arm/Group Title Part 1 Cohort A: Vehicle Cream Part 1 Cohort A Ruxolitinib 0.5% Cream Part 1 Cohort B: Vehicle Cream Part 1 Cohort B Ruxolitinib 1.0% Cream Part 1 Cohort C: Vehicle Cream Part 1 Cohort C Ruxolitinib 1.5% Cream Part 2 Cohort D: INCB18424 Part 2 Cohort D Calcipotriene (Dovonex®) Part 2 Cohort E: INCB18424 Part 2 Cohort E Betamethasone Dipropionate (Diprolene® AF)
    Arm/Group Description Vehicle cream was applied once a day for 28 days Ruxolitinib 0.5% was applied once a day for 28 days Vehicle Cream was applied once a day for 28 days Ruxolitinib 1.0% was applied once a day for 28 days Vehicle Cream was applied once a day for 28 days Ruxolitinib 1.5% was applied once a day for 28 days up to 1/5% Ruolitinib cream was applied twice a day for 28 days Calcipotriene (Dovonex®) 0.005% cream was applied twice a day for 28 days up to 1.5% Ruxolitinib cream was applied twice a day Betamethasone Dipropionate (Diprolene® AF) 0.05% cream were applied twice a day for 28 days
    Period Title: Overall Study
    STARTED 6 6 6 6 6 6 6 6 5 5
    COMPLETED 5 5 6 6 6 6 5 5 5 5
    NOT COMPLETED 1 1 0 0 0 0 1 1 0 0

    Baseline Characteristics

    Arm/Group Title 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
    Arm/Group Description Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Ruxolitinib 1.0% cream vs. vehicle cream once a day for 28 days Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days Total of all reporting groups
    Overall Participants 6 6 6 6 5 29
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    42.2
    (14.25)
    48.8
    (10.25)
    55.8
    (10.38)
    50.2
    (21.13)
    46.2
    (10.08)
    48.7
    (13.79)
    Sex/Gender, Customized (Number) [Number]
    Male
    4
    66.7%
    5
    83.3%
    4
    66.7%
    3
    50%
    4
    80%
    20
    69%
    Female
    2
    33.3%
    1
    16.7%
    2
    33.3%
    3
    50%
    1
    20%
    9
    31%
    Race/Ethnicity, Customized (Number) [Number]
    Asian
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    3.4%
    White or Caucasian
    5
    83.3%
    6
    100%
    5
    83.3%
    6
    100%
    5
    100%
    27
    93.1%
    Other
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    1
    3.4%
    Race/Ethnicity, Customized (Number) [Number]
    Hispanic or Latino
    0
    0%
    1
    16.7%
    0
    0%
    1
    16.7%
    1
    20%
    3
    10.3%
    Not Hispanic or Latino
    6
    100%
    5
    83.3%
    6
    100%
    5
    83.3%
    4
    80%
    26
    89.7%

    Outcome Measures

    1. Primary Outcome
    Title Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Part 1 Cohort A: Vehicle Cream Part 1 Cohort A: Ruxolitinib 0.5% Cream Part 1 Cohort B: Vehicle Cream Part 1 Cohort B: Ruxolitinib 1.0% Cream Part 1 Cohort C: Vehicle Cream Part 1 Cohort C: Ruxolitinib 1.5% Cream Part 2 Cohort D: INCB18424 Part 2 Cohort D: Calcipotriene (Dovonex®) Part 2 Cohort E: INCB18424 Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF)
    Arm/Group Description Vehicle cream was applied once a day for 28 days Ruxolitinib 0.5% once a day for 28 days Vehicle cream was applied once a day for 28 days Ruxolitinib 1.0% cream once a day for 28 days Vehicle cream was applied twice a day for 28 days Ruxolitinib 1.5% twice a day for 28 days up to 1.5% Ruxolitinib cream was applied twice a day Calcipotriene (Dovonex®) 0.005% cream was applied twice a day up to 1.5% Ruxolitinib cream was applied twice a day Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days
    Measure Participants 6 6 6 6 6 6 6 6 5 5
    Day 8 - Erythema
    -0.5
    (0.84)
    -0.5
    (0.55)
    -0.8
    (0.41)
    -1.0
    (0.63)
    -0.7
    (0.82)
    -1.2
    (0.75)
    -1.2
    (1.10)
    -0.8
    (0.84)
    -1.0
    (0.82)
    -1.3
    (0.96)
    Day 8 - Scaling
    -0.2
    (0.41)
    -0.2
    (0.41)
    0.0
    (0.00)
    -0.2
    (0.41)
    -0.7
    (0.82)
    -1.2
    (0.41)
    -0.6
    (0.89)
    -0.6
    (0.55)
    -0.8
    (0.50)
    -0.8
    (0.50)
    Day 8 - Thickness
    -0.7
    (1.03)
    -0.7
    (1.03)
    -0.2
    (0.41)
    -0.3
    (0.52)
    -0.3
    (0.52)
    -0.8
    (0.75)
    -0.4
    (0.89)
    -0.6
    (0.55)
    -0.5
    (0.58)
    -0.8
    (0.96)
    Day 15 - Erythema
    -0.7
    (0.82)
    -0.7
    (0.82)
    -0.8
    (0.75)
    -1.0
    (0.63)
    -0.5
    (0.84)
    -1.2
    (0.98)
    -1.0
    (0.71)
    -0.8
    (0.45)
    -1.0
    (1.00)
    -1.2
    (0.84)
    Day 15 - Scaling
    -0.3
    (0.52)
    -0.3
    (0.52)
    -0.2
    (0.75)
    -0.3
    (0.82)
    -0.7
    (0.82)
    -1.0
    (0.00)
    -0.2
    (0.84)
    -0.4
    (0.55)
    -0.8
    (0.45)
    -1.2
    (0.45)
    Day 15 - Thickness
    -0.3
    (0.52)
    -0.3
    (0.52)
    -0.2
    (0.41)
    -0.3
    (0.52)
    -0.5
    (0.55)
    -0.8
    (0.41)
    -0.6
    (1.14)
    -0.8
    (0.84)
    -0.6
    (1.14)
    -0.6
    (0.89)
    Day 22 - Erythema
    -0.8
    (0.84)
    -1.0
    (0.71)
    -1.0
    (0.63)
    -1.5
    (0.84)
    -0.3
    (0.82)
    -1.2
    (0.98)
    -1.8
    (1.30)
    -1.0
    (1.00)
    -1.4
    (0.89)
    -1.6
    (0.55)
    Day 22 - Scaling
    -0.4
    (0.55)
    -0.6
    (0.55)
    -0.5
    (0.55)
    -0.8
    (0.75)
    -0.5
    (0.84)
    -1.2
    (0.41)
    -0.6
    (1.14)
    -0.6
    (0.89)
    -0.8
    (0.45)
    -1.0
    (0.71)
    Day 22 - Thickness
    -0.2
    (1.10)
    -0.6
    (0.89)
    -0.3
    (0.52)
    -0.5
    (0.84)
    -0.8
    (0.75)
    -1.2
    (0.75)
    -1.0
    (1.00)
    -0.8
    (0.45)
    -1.0
    (0.71)
    -0.8
    (0.84)
    Day 28 - Erythema
    -0.6
    (0.55)
    -0.4
    (0.55)
    -1.2
    (0.41)
    -1.7
    (0.52)
    -0.5
    (0.55)
    -1.0
    (0.63)
    -1.4
    (1.14)
    -1.2
    (0.84)
    -1.2
    (0.84)
    -1.8
    (0.84)
    Day 28 - Scaling
    -0.2
    (0.45)
    -0.4
    (0.55)
    -0.7
    (0.52)
    -1.0
    (0.63)
    -0.5
    (0.55)
    -1.2
    (0.41)
    -0.8
    (1.10)
    -0.8
    (0.84)
    -0.8
    (0.45)
    -1.2
    (0.84)
    Day 28 - Thickness
    -0.4
    (0.55)
    -0.2
    (0.45)
    -0.3
    (0.52)
    -1.0
    (0.63)
    -1.2
    (0.75)
    -1.5
    (0.55)
    -1.0
    (1.00)
    -1.0
    (0.00)
    -1.0
    (0.71)
    -1.2
    (0.45)
    Day 56/ET - Erythema
    -0.5
    (1.05)
    -0.3
    (0.52)
    0.0
    (0.63)
    -0.2
    (0.41)
    -0.5
    (0.84)
    -0.5
    (0.84)
    -1.0
    (0.63)
    -1.2
    (1.47)
    0.2
    (0.84)
    -0.6
    (0.55)
    Day 56/ET - Scaling
    -0.2
    (0.41)
    -0.2
    (0.41)
    0.3
    (0.82)
    0.7
    (0.82)
    -0.7
    (0.82)
    -0.7
    (0.82)
    -0.8
    (0.75)
    -0.7
    (1.21)
    -0.2
    (0.84)
    -0.4
    (0.89)
    Day 56/ET - Thickness
    -0.3
    (0.52)
    -0.3
    (0.52)
    0.0
    (0.75)
    0.2
    (0.75)
    -0.7
    (1.03)
    -0.8
    (0.98)
    -1.2
    (0.75)
    -1.0
    (0.63)
    0.0
    (0.71)
    -0.4
    (0.55)
    2. Primary Outcome
    Title Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Part 1 Cohort A: Vehicle Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Part 1 Cohort B: Vehicle Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream Part 1 Cohort C: Vehicle Cream Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Part 2 Cohort D: INCB18424 Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) Part 2 Cohort E: INCB18424 Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)
    Arm/Group Description placebo cream Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Placebo cream Ruxolitinib 1.0% cream once a day for 28 days Vehicle Placebo cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days up to 1.5% Ruxolitinib Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days up to 1.5% Ruxolitinib cream Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
    Measure Participants 6 6 6 6 6 6 6 6 5 5
    Day 8
    -1.3
    (1.97)
    -1.3
    (1.21)
    -1.0
    (0.63)
    -1.7
    (1.37)
    -1.7
    (2.07)
    -3.2
    (1.72)
    -2.4
    (2.70)
    -2.2
    (1.79)
    -2.3
    (0.96)
    -2.8
    (1.71)
    Day 15
    -1.3
    (1.75)
    -1.3
    (1.75)
    -1.3
    (2.07)
    -2.0
    (1.79)
    -1.7
    (2.07)
    -3.0
    (1.26)
    -2.0
    (2.55)
    -2.2
    (1.79)
    -2.4
    (2.07)
    -3.0
    (1.87)
    Day 22
    -1.4
    (1.95)
    -2.2
    (1.79)
    -1.8
    (0.98)
    -3.0
    (2.00)
    -1.7
    (2.25)
    -3.5
    (1.76)
    -3.6
    (3.13)
    -2.6
    (1.82)
    -3.2
    (1.64)
    -3.4
    (1.67)
    Day 28
    -1.2
    (1.30)
    -1.0
    (1.41)
    -2.2
    (1.17)
    -3.8
    (1.60)
    -2.2
    (1.60)
    -3.7
    (1.37)
    -3.4
    (2.70)
    -3.2
    (1.30)
    -3.0
    (1.58)
    -4.2
    (1.79)
    Day 56/ET
    -1.5
    (1.87)
    -1.3
    (1.21)
    0.5
    (1.87)
    0.5
    (1.38)
    -1.8
    (2.23)
    -2.0
    (2.10)
    -3.2
    (1.60)
    -3.0
    (2.90)
    0.0
    (2.00)
    -1.4
    (1.67)
    3. Primary Outcome
    Title Number of Participants With Treatment Emergent Adverse Events
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle 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)
    Arm/Group Description Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Ruxolitinib 1.0% vs. placebo cream once a day for 28 days Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
    Measure Participants 6 6 6 5 5
    Count of Participants [Participants]
    6
    100%
    1
    16.7%
    5
    83.3%
    4
    66.7%
    2
    40%
    4. Primary Outcome
    Title Pharmacokinetics Parameter : Skin Flux of INCB018424
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle 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)
    Arm/Group Description Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Ruxolitinib 1.0% vs. placebo cream once a day for 28 days Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
    Measure Participants 6 6 6 6 5
    Mean (Standard Deviation) [ng/cm^2/h]
    54.2
    (40.8)
    151
    (70)
    422
    (200)
    363
    (215)
    383
    (256)
    5. Primary Outcome
    Title Pharmacokinetics Parameter : Bioavailability of INCB018424
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle 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)
    Arm/Group Description Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Ruxolitinib 1.0% vs. placebo cream once a day for 28 days Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
    Measure Participants 6 6 6 6 5
    Mean (Standard Deviation) [Percentage of dosage]
    2.8
    (3.2)
    3.0
    (1.9)
    3.0
    (1.9)
    2.7
    (1.1)
    2.7
    (2.3)
    6. Secondary Outcome
    Title Change in Target Lesion Area Compared to Baseline
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cohort A: Vehicle Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream Cohort B: Vehicle Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle Cohort C: Vehicle Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Cohort D: INCB18424 Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) Cohort E: INCB18424 Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)
    Arm/Group Description Placebo cream Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Placebo cream Ruxolitinib 1.0% vs. placebo cream once a day for 28 days Placebo cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinb to 1.5% Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Ruxolitinib up to 1.5% Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days
    Measure Participants 6 6 6 6 6 6 6 6 5 5
    Mean (Standard Deviation) [cm^2]
    0.35
    (4.872)
    1.53
    (9.760)
    0.45
    (3.775)
    -3.18
    (8.651)
    -4.03
    (12.303)
    -11.45
    (13.851)
    -5.22
    (6.203)
    -2.54
    (6.778)
    1.53
    (1.624)
    -0.48
    (5.892)

    Adverse Events

    Time Frame Up to approximately 2 months
    Adverse Event Reporting Description Adverse Events were reported at the participant level, not the treatment level within each cohort.
    Arm/Group Title 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
    Arm/Group Description Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days Ruxolitinib 1.0% cream once a day for 28 days Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days Total
    All Cause Mortality
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/5 (0%) 0/29 (0%)
    Serious Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/5 (0%) 0/29 (0%)
    Other (Not Including Serious) Adverse Events
    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
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 1/6 (16.7%) 5/6 (83.3%) 4/6 (66.7%) 2/5 (40%) 18/29 (62.1%)
    Cardiac disorders
    ATRIOVENTRICULAR BLOCK 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    SINUS BRADYCARDIA 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    General disorders
    APPLICATION SITE REACTION 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    FEELING COLD 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    PAIN 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    Infections and infestations
    NASOPHARYNGITIS 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 2/29 (6.9%) 2
    UPPER RESPIRATORY TRACT INFECTION 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 3/29 (10.3%) 3
    Injury, poisoning and procedural complications
    CONTUSION 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    PROCEDURAL PAIN 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    SUNBURN 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    BLOOD GLUCOSE INCREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 2/29 (6.9%) 2
    ELECTROCARDIOGRAM QT INTERVAL ABNORMAL 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 1/29 (3.4%) 1
    ELECTROCARDIOGRAM QT PROLONGED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 1/29 (3.4%) 1
    ELECTROCARDIOGRAM T WAVE ABNORMAL 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    GAMMA-GLUTAMYLTRANSFERASE INCREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 3 0/5 (0%) 0 1/29 (3.4%) 3
    HAEMATOCRIT DECREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    HAEMOGLOBIN DECREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    RETICULOCYTE COUNT INCREASED 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/5 (0%) 0 1/29 (3.4%) 2
    URINE KETONE BODY PRESENT 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 1/29 (3.4%) 1
    Nervous system disorders
    HEADACHE 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    Skin and subcutaneous tissue disorders
    DRY SKIN 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 1/5 (20%) 3 3/29 (10.3%) 5
    ERYTHEMA 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/5 (20%) 2 2/29 (6.9%) 3
    PRURITUS 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 0/5 (0%) 0 4/29 (13.8%) 4
    RASH PRURITIC 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1
    SKIN EXFOLIATION 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 1/5 (20%) 2 2/29 (6.9%) 4
    SKIN IRRITATION 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 1/29 (3.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Clinical Study Agreement

    Results Point of Contact

    Name/Title Incyte Corporation Call Center (US)
    Organization Incyte
    Phone 1.855.463.3463
    Email medinfo@incyte.com
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT00820950
    Other Study ID Numbers:
    • INCB 18424-201
    First Posted:
    Jan 12, 2009
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022