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A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib 0.15% Cream QD
Ruxolitinib 0.5% Cream QD
Ruxolitinib 1.5% Cream QD
Ruxolitinib 1.5% Cream BID
Triamcinolone 0.1% Cream BID
Vehicle Cream BID
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, eczema, pruritus, Janus kinase (JAK) inhibitors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
  • Participants with a history of AD for at least 2 years.
  • Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
  • Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
  • Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

Exclusion Criteria:

  • Participants with evidence of active acute or chronic infections.
  • Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
  • Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
  • Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
  • Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.

  • Participants with cytopenias at screening, defined as:

    • Leukocytes < 3.0 × 10^9/L.
    • Neutrophils < lower limit of normal.
    • Hemoglobin < 10 g/dL.
    • Lymphocytes < 0.8 × 10^9/L
    • Platelets < 100 × 10^9/L.

  • Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:

    • Serum creatinine > 1.5 mg/dL.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
  • Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
  • Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

Sites / Locations

  • UAB DERMATOLOGY, 2000 6th Avenue South
  • BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
  • ENCINO RESEARCH CENTER, 16133 Ventura Blvd
  • DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
  • DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
  • INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
  • SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
  • NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
  • DS RESEARCH, 2241 Green Valley Road
  • THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
  • DERMRESEARCH, 1169 Eastern Parkway 2310
  • DS RESEARCH, 3810 Springhurst Blvd
  • ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
  • TUFTS MEDICAL CENTER, 800 Washington Street
  • HENRY FORD HOSPITAL, 3031 West Grand Blvd
  • WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
  • WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
  • ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
  • HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
  • DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
  • WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
  • DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
  • RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
  • CENTRAL SOONER RESEARCH, 900 North Porter
  • PARISH DERMATOLOGY, INC, 1845 Walnut Street
  • PEAK RESEARCH LLC, 2589 Washington Rd
  • ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
  • DERMRESEARCH INC., 8140 North Mopac Expressway
  • J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
  • CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
  • SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
  • CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
  • DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
  • CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
  • CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway
  • INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
  • DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
  • WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
  • CCA MEDICAL RESEARCH, 95 Bayly Street West
  • SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
  • LYNDERM RESEARCH INC, 25 Main Street Markham North
  • DERMEDGE RESEARCH INC., 333 Lakeshore Road West
  • NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
  • RESEARCH BY ICLS, 1344 Cornwall Road
  • OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
  • SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
  • YORK DERMATOLOGY CENTER, 250 Harding Blvd West
  • RESEARCH TORONTO, 208 Bloor Street West
  • K. PAPP CLINICAL RESEARCH, 135 Union Street East
  • XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
  • WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
  • CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Double Blind (DB): Vehicle BID

DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID

DB: Ruxolitinib 0.15% Once Daily (QD)

DB: Ruxolitinib 0.5% QD

DB: Ruxolitinib 1.5% QD

DB: Ruxolitinib 1.5% BID

Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID

OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID

OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID

OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID

OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID

OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID

Arm Description

Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.

Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.

Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.

Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.

Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.

Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Outcomes

Primary Outcome Measures

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

Secondary Outcome Measures

Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
Percentage Change From Baseline in EASI Score at Week 4
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time to Achieve EASI-50
Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.

Full Information

First Posted
January 3, 2017
Last Updated
March 16, 2021
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03011892
Brief Title
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Official Title
A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, eczema, pruritus, Janus kinase (JAK) inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double Blind (DB): Vehicle BID
Arm Type
Placebo Comparator
Arm Description
Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
Arm Title
DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
Arm Type
Active Comparator
Arm Description
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
Arm Title
DB: Ruxolitinib 0.15% Once Daily (QD)
Arm Type
Experimental
Arm Description
Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
Arm Title
DB: Ruxolitinib 0.5% QD
Arm Type
Experimental
Arm Description
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
Arm Title
DB: Ruxolitinib 1.5% QD
Arm Type
Experimental
Arm Description
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
Arm Title
DB: Ruxolitinib 1.5% BID
Arm Type
Experimental
Arm Description
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
Arm Title
Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
Arm Type
Placebo Comparator
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Arm Title
OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID
Arm Type
Active Comparator
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Arm Title
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
Arm Type
Experimental
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Arm Title
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
Arm Type
Experimental
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Arm Title
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
Arm Type
Experimental
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Arm Title
OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID
Arm Type
Experimental
Arm Description
Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 0.15% Cream QD
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib 0.15% cream QD
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 0.5% Cream QD
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib 0.5% cream QD
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 1.5% Cream QD
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib 1.5% cream QD
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 1.5% Cream BID
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib 1.5% cream BID
Intervention Type
Drug
Intervention Name(s)
Triamcinolone 0.1% Cream BID
Intervention Description
Triamcinolone 0.1% cream BID
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream BID
Intervention Description
Vehicle cream BID
Primary Outcome Measure Information:
Title
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
Description
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
Description
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame
Baseline and Week 4
Title
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
Description
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame
Baseline and Week 4
Title
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
Description
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame
Baseline, Week 2 and 8
Title
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Description
The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
Time Frame
Week 2, 4 and 8
Title
Percentage Change From Baseline in EASI Score at Week 4
Description
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Time Frame
Baseline and Week 4
Title
Time to Achieve EASI-50
Description
Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
Time Frame
From Baseline to Week 8
Title
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
Description
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Time Frame
Week 2, 4 and 8
Title
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Description
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
Time Frame
Baseline, Week 2, 4 and 8
Title
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Description
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria. Participants with a history of AD for at least 2 years. Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline. Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline. Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit. Exclusion Criteria: Participants with evidence of active acute or chronic infections. Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline. Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer). Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis). Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments. Participants with cytopenias at screening, defined as: Leukocytes < 3.0 × 10^9/L. Neutrophils < lower limit of normal. Hemoglobin < 10 g/dL. Lymphocytes < 0.8 × 10^9/L Platelets < 100 × 10^9/L. Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following: Serum creatinine > 1.5 mg/dL. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal. Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted). Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kuligowski, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
UAB DERMATOLOGY, 2000 6th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Facility Name
ENCINO RESEARCH CENTER, 16133 Ventura Blvd
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
DS RESEARCH, 2241 Green Valley Road
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DERMRESEARCH, 1169 Eastern Parkway 2310
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
DS RESEARCH, 3810 Springhurst Blvd
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
TUFTS MEDICAL CENTER, 800 Washington Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
HENRY FORD HOSPITAL, 3031 West Grand Blvd
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
CENTRAL SOONER RESEARCH, 900 North Porter
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
PARISH DERMATOLOGY, INC, 1845 Walnut Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
PEAK RESEARCH LLC, 2589 Washington Rd
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
DERMRESEARCH INC., 8140 North Mopac Expressway
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
CCA MEDICAL RESEARCH, 95 Bayly Street West
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
LYNDERM RESEARCH INC, 25 Main Street Markham North
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DERMEDGE RESEARCH INC., 333 Lakeshore Road West
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
RESEARCH BY ICLS, 1344 Cornwall Road
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
YORK DERMATOLOGY CENTER, 250 Harding Blvd West
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
RESEARCH TORONTO, 208 Bloor Street West
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5Sz 2B4
Country
Canada
Facility Name
K. PAPP CLINICAL RESEARCH, 135 Union Street East
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine
City
Saint-jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 3B8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33982267
Citation
Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.
Results Reference
derived
PubMed Identifier
31629805
Citation
Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

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