Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
NCT ID: NCT03745638
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
631 participants
INTERVENTIONAL
2018-12-20
2020-12-01
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
QUADRUPLE
Study Groups
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VC Period: Vehicle Cream BID
Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
VC Period: Ruxolitinib 0.75% Cream BID
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
VC Period: Ruxolitinib 1.5% Cream BID
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the Long-term Safety (LTS) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who applied vehicle cream BID during the VC Period, were randomized to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
LTS Period: Ruxolitinib 0.75% Cream
Arm description: Participants who applied ruxolitinib 0.75% cream during VC Period, continued applying ruxolitinib 0.75% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
LTS Period: Ruxolitinib 1.5% Cream
Arm description: Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 52 during the LTS Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Interventions
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Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
* AD duration of at least 2 years.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and Baseline \[Vehicle Controlled (VC) Period\] and 0 to 4 at Week 8 \[Long-Term Safety (LTS) Period\].
* Participants with percentage of Body Surface Area (% BSA) (excluding scalp) of AD involvement of 3% to 20% at screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
* Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
* Participants who have at least 1 "target lesion" that measures approximately 10 cm\^2 or more at screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
* Willingness to avoid pregnancy or fathering of children.
Exclusion Criteria
* Concurrent conditions and history of other diseases:
* Immunocompromised.
* Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
* Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
* Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
* Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
* Other types of eczema.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of any of the following treatments within the indicated washout period before Baseline:
* 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg. dupilumab).
* 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg. mycophenolate or tacrolimus).
* 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
* 1 week - use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.
* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
* Positive serology test results at screening for Human Immunodeficiency Virus (HIV) antibody.
* Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
* Pregnant or lactating participants, or those considering pregnancy.
* History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
12 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael E. Kuligowski, MD, PhD, MBA
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Cahaba Dermatology
Birmingham, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists Inc
Oceanside, California, United States
Integrated Research Group Inc.
Riverside, California, United States
Advanced Rx Clinical Research
Westminster, California, United States
Clearlyderm Boca Raton - BTC - PPDS
Boca Raton, Florida, United States
Olympian Clinical Research
Largo, Florida, United States
Acevedo Clinical Research
Miami, Florida, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
AdvancedPharma CR LLC
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Aeroallergy Research Lab Of Savannah
Savannah, Georgia, United States
Clinical Research Atlanta - ERN-PPDS
Stockbridge, Georgia, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States
DS Research
New Albany, Indiana, United States
Kansas City Dermatology P.A.
Overland Park, Kansas, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Michael W Simon MD
Nicholasville, Kentucky, United States
DermAssociates
Rockville, Maryland, United States
Henry Ford Medical Center
Detroit, Michigan, United States
JDR Dermatology Research
Las Vegas, Nevada, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
Sadick Dermatology
New York, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Ohio Pediatric Research Assn Inc
Huber Heights, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Cyn3rgy Research - Clinedge - PPDS
Gresham, Oregon, United States
Clinical Research Institute Of Southern Oregon - Crisor
Medford, Oregon, United States
Oregon Medical Research Center PC
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Synexus Clinical Research Us Inc. Greer
Greer, South Carolina, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Family Medicine Associates Of Texas
Carrollton, Texas, United States
Progressive Clinical Research PA
San Antonio, Texas, United States
Jordan Valley Medical Center
West Jordan, Utah, United States
PI Coor Clinical Research LLC
Burke, Virginia, United States
West End Dermatology
Henrico, Virginia, United States
Lynderm Research Inc
Markham, Ontario, Canada
York Dermatology Center
Richmond Hill, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Windsor Clinical Research Inc.
Windsor, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Siena Medical Reserch Corporation
Westmount, Quebec, Canada
CHRU de Brest - Hopital Morvan
Brest, , France
Le Bateau Blanc - Imm. A
Martigues, , France
Hôpital L'archet 2
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital Charles Nicolle
Rouen, , France
Elben Klinken Stade - Buxtehude
Buxtehude, Lower Saxony, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Synexus (DRS) - Synexus Magyarország Kft. Budapest
Budapest, , Hungary
Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
Debrecen, , Hungary
Synexus (DRS) - Synexus Magyarország Kft. Gyula
Gyula, , Hungary
Pécsi Tudományegyetem
Pécs, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
Zalaegerszeg, , Hungary
Fondazione Policlinico Universitario A Gemelli
Roma, , Italy
Synexus - Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne ADAMAR
Wroclaw, Lower Silesian Voivodeship, Poland
ETG Zgierz
Zgierz, Lódzkie, Poland
Klinika Ambroziak
Warsaw, Masovian Voivodeship, Poland
Synexus - Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Laser Clinic S.C.
Szczecin, West Pomeranian Voivodeship, Poland
Synexus - Katowice
Katowice, , Poland
Centrum Medyczne Krakow - PRATIA - PPDS
Krakow, , Poland
ETG Lublin
Lublin, , Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
Tarnów, , Poland
Medycyna Kliniczna Marzena Waszczak-Jeka
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
Royalderm
Warsaw, , Poland
Countries
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References
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Simpson EL, Augustin M, Thaci D, Misery L, Armstrong AW, Blauvelt A, Papp KA, Szepietowski JC, Boguniewicz M, Kwatra SG, Kallender H, Sturm D, Ren H, Kircik L. Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies. Am J Clin Dermatol. 2025 Jan;26(1):121-137. doi: 10.1007/s40257-024-00901-z. Epub 2024 Nov 15.
Blauvelt A, Kallender H, Sturm D, Li Q, Ren H, Eichenfield LF. Efficacy and Safety of Ruxolitinib Cream in Atopic Dermatitis Based on Previous Medication History. Dermatol Ther (Heidelb). 2024 Nov;14(11):3161-3174. doi: 10.1007/s13555-024-01272-3. Epub 2024 Oct 7.
Eichenfield LF, Simpson EL, Papp K, Szepietowski JC, Blauvelt A, Kircik L, Silverberg JI, Siegfried EC, Kuligowski ME, Venturanza ME, Kallender H, Ren H, Paller AS. Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Am J Clin Dermatol. 2024 Jul;25(4):669-683. doi: 10.1007/s40257-024-00855-2. Epub 2024 May 2.
Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.
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.
Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.
Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Plain Language Summary of Results
Other Identifiers
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2018-003712-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-303
Identifier Type: -
Identifier Source: org_study_id
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