Clinical trial NCT03011892: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
eczema
pruritus
Janus kinase (JAK) inhibitors
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 4
measure: 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
timeFrame: Baseline and Week 4
measure: Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
timeFrame: Baseline, Week 2 and 8
measure: Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
timeFrame: Week 2, 4 and 8
measure: Percentage Change From Baseline in EASI Score at Week 4
timeFrame: Baseline and Week 4
measure: Time to Achieve EASI-50
timeFrame: From Baseline to Week 8
measure: 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
timeFrame: Week 2, 4 and 8
measure: Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
timeFrame: Baseline, Week 2, 4 and 8
measure: Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB DERMATOLOGY, 2000 6th Avenue South
state: Alabama
city: Bryant
country: United States
facility: BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
state: Arkansas
city: Encino
country: United States
facility: ENCINO RESEARCH CENTER, 16133 Ventura Blvd
state: California
city: Los Angeles
country: United States
facility: DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
state: California
city: Oceanside
country: United States
facility: DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
state: California
city: Riverside
country: United States
facility: INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
state: California
city: San Luis Obispo
country: United States
facility: SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
state: California
city: Trumbull
country: United States
facility: NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
state: Connecticut
city: New Albany
country: United States
facility: DS RESEARCH, 2241 Green Valley Road
state: Indiana
city: Plainfield
country: United States
facility: THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
state: Indiana
city: Louisville
country: United States
facility: DERMRESEARCH, 1169 Eastern Parkway 2310
state: Kentucky
city: Louisville
country: United States
facility: DS RESEARCH, 3810 Springhurst Blvd
state: Kentucky
city: Beverly
country: United States
facility: ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
state: Massachusetts
city: Boston
country: United States
facility: TUFTS MEDICAL CENTER, 800 Washington Street
state: Massachusetts
city: Detroit
country: United States
facility: HENRY FORD HOSPITAL, 3031 West Grand Blvd
state: Michigan
city: Saint Louis
country: United States
facility: WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
state: Missouri
city: Saint Louis
country: United States
facility: WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
state: Missouri
city: Portsmouth
country: United States
facility: ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
state: New Hampshire
city: Berlin
country: United States
facility: HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
state: New Jersey
city: High Point
country: United States
facility: DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
state: North Carolina
city: Raleigh
country: United States
facility: WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
state: North Carolina
city: Bexley
country: United States
facility: DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
state: Ohio
city: Cleveland
country: United States
facility: RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
state: Ohio
city: Norman
country: United States
facility: CENTRAL SOONER RESEARCH, 900 North Porter
state: Oklahoma
city: Philadelphia
country: United States
facility: PARISH DERMATOLOGY, INC, 1845 Walnut Street
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK RESEARCH LLC, 2589 Washington Rd
state: Pennsylvania
city: Arlington
country: United States
facility: ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
state: Texas
city: Austin
country: United States
facility: DERMRESEARCH INC., 8140 North Mopac Expressway
state: Texas
city: College Station
country: United States
facility: J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
state: Texas
city: Houston
country: United States
facility: CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
state: Texas
city: Houston
country: United States
facility: SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
state: Texas
city: San Antonio
country: United States
facility: CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
state: Texas
city: San Antonio
country: United States
facility: DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
state: Texas
city: Webster
country: United States
facility: CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
state: Texas
city: Charlottesville
country: United States
facility: CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway
state: Virginia
city: Calgary
country: Canada
facility: INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
state: Alberta
city: Surrey
country: Canada
facility: DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
state: British Columbia
city: Winnipeg
country: Canada
facility: WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
state: Manitoba
city: Ajax
country: Canada
facility: CCA MEDICAL RESEARCH, 95 Bayly Street West
state: Ontario
city: Barrie
country: Canada
facility: SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
state: Ontario
city: Markham
country: Canada
facility: LYNDERM RESEARCH INC, 25 Main Street Markham North
state: Ontario
city: Mississauga
country: Canada
facility: DERMEDGE RESEARCH INC., 333 Lakeshore Road West
state: Ontario
city: North Bay
country: Canada
facility: NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
state: Ontario
city: Oakville
country: Canada
facility: RESEARCH BY ICLS, 1344 Cornwall Road
state: Ontario
city: Ottawa
country: Canada
facility: OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
state: Ontario
city: Peterborough
country: Canada
facility: SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
state: Ontario
city: Richmond Hill
country: Canada
facility: YORK DERMATOLOGY CENTER, 250 Harding Blvd West
state: Ontario
city: Toronto
country: Canada
facility: RESEARCH TORONTO, 208 Bloor Street West
state: Ontario
city: Waterloo
country: Canada
facility: K. PAPP CLINICAL RESEARCH, 135 Union Street East
state: Ontario
city: Windsor
country: Canada
facility: XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
state: Ontario
city: Windsor
country: Canada
facility: WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
state: Ontario
city: Saint-jerome
country: Canada
facility: CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine
state: Quebec
Study officials:
affiliation: Incyte Corporation
name: Michael Kuligowski, MD
role: STUDY_DIRECTOR
References:
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.
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.