A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
NCT ID: NCT03011892
Last Updated: 2021-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
307 participants
INTERVENTIONAL
2017-01-09
2018-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Double Blind (DB): Vehicle BID
Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
Vehicle Cream BID
Vehicle cream BID
DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
Triamcinolone 0.1% Cream BID
Triamcinolone 0.1% cream BID
Vehicle Cream BID
Vehicle cream BID
DB: Ruxolitinib 0.15% Once Daily (QD)
Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
Ruxolitinib 0.15% Cream QD
Ruxolitinib 0.15% cream QD
DB: Ruxolitinib 0.5% QD
Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
Ruxolitinib 0.5% Cream QD
Ruxolitinib 0.5% cream QD
DB: Ruxolitinib 1.5% QD
Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
Ruxolitinib 1.5% Cream QD
Ruxolitinib 1.5% cream QD
DB: Ruxolitinib 1.5% BID
Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID
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.
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
Interventions
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Ruxolitinib 0.15% Cream QD
Ruxolitinib 0.15% cream QD
Ruxolitinib 0.5% Cream QD
Ruxolitinib 0.5% cream QD
Ruxolitinib 1.5% Cream QD
Ruxolitinib 1.5% cream QD
Ruxolitinib 1.5% Cream BID
Ruxolitinib 1.5% cream BID
Triamcinolone 0.1% Cream BID
Triamcinolone 0.1% cream BID
Vehicle Cream BID
Vehicle cream BID
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Kuligowski, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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UAB DERMATOLOGY, 2000 6th Avenue South
Birmingham, Alabama, United States
BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
Bryant, Arkansas, United States
ENCINO RESEARCH CENTER, 16133 Ventura Blvd
Encino, California, United States
DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
Los Angeles, California, United States
DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
Oceanside, California, United States
INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
Riverside, California, United States
SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
San Luis Obispo, California, United States
NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
Trumbull, Connecticut, United States
DS RESEARCH, 2241 Green Valley Road
New Albany, Indiana, United States
THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
Plainfield, Indiana, United States
DERMRESEARCH, 1169 Eastern Parkway 2310
Louisville, Kentucky, United States
DS RESEARCH, 3810 Springhurst Blvd
Louisville, Kentucky, United States
ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
Beverly, Massachusetts, United States
TUFTS MEDICAL CENTER, 800 Washington Street
Boston, Massachusetts, United States
HENRY FORD HOSPITAL, 3031 West Grand Blvd
Detroit, Michigan, United States
WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
St Louis, Missouri, United States
WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
St Louis, Missouri, United States
ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
Portsmouth, New Hampshire, United States
HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
Berlin, New Jersey, United States
DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
High Point, North Carolina, United States
WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
Raleigh, North Carolina, United States
DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
Bexley, Ohio, United States
RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
Cleveland, Ohio, United States
CENTRAL SOONER RESEARCH, 900 North Porter
Norman, Oklahoma, United States
PARISH DERMATOLOGY, INC, 1845 Walnut Street
Philadelphia, Pennsylvania, United States
PEAK RESEARCH LLC, 2589 Washington Rd
Upper Saint Clair, Pennsylvania, United States
ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
Arlington, Texas, United States
DERMRESEARCH INC., 8140 North Mopac Expressway
Austin, Texas, United States
J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
College Station, Texas, United States
CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
Houston, Texas, United States
SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
Houston, Texas, United States
CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
San Antonio, Texas, United States
DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
San Antonio, Texas, United States
CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
Webster, Texas, United States
CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway
Charlottesville, Virginia, United States
INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
Calgary, Alberta, Canada
DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
Surrey, British Columbia, Canada
WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
Winnipeg, Manitoba, Canada
CCA MEDICAL RESEARCH, 95 Bayly Street West
Ajax, Ontario, Canada
SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
Barrie, Ontario, Canada
LYNDERM RESEARCH INC, 25 Main Street Markham North
Markham, Ontario, Canada
DERMEDGE RESEARCH INC., 333 Lakeshore Road West
Mississauga, Ontario, Canada
NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
North Bay, Ontario, Canada
RESEARCH BY ICLS, 1344 Cornwall Road
Oakville, Ontario, Canada
OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
Ottawa, Ontario, Canada
SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
Peterborough, Ontario, Canada
YORK DERMATOLOGY CENTER, 250 Harding Blvd West
Richmond Hill, Ontario, Canada
RESEARCH TORONTO, 208 Bloor Street West
Toronto, Ontario, Canada
K. PAPP CLINICAL RESEARCH, 135 Union Street East
Waterloo, Ontario, Canada
XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
Windsor, Ontario, Canada
WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
Windsor, Ontario, Canada
CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine
Saint-Jérôme, Quebec, Canada
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 18424-206
Identifier Type: -
Identifier Source: org_study_id
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