TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
NCT ID: NCT03745651
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
618 participants
INTERVENTIONAL
2018-12-20
2020-11-09
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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LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
LTS Period: Ruxolitinib 0.75% Cream BID
Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
LTS Period: Ruxolitinib 1.5% Cream BID
Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
Vehicle Control (VC) Period: Vehicle Cream BID
Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Vehicle cream
Ruxolitinib matching vehicle cream.
VC Period: Ruxolitinib 0.75% Cream BID
Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
VC Period: Ruxolitinib 1.5% Cream BID
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
Interventions
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Ruxolitinib cream
Ruxolitinib 0.75% or 1.5% cream.
Vehicle cream
Ruxolitinib matching vehicle cream.
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 (VC Period) and 0 to 4 at Week 8 (LTS Period).
* Participants with percentage 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 (e.g. dupilumab).
* 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. 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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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Center For Dermatology Cosmetic And Laser Surgery
Fremont, California, United States
Marvel Clinical Research - Clinedge - PPDS
Huntington Beach, California, United States
Allergy And Asthma Associates Of Southern California - CRN
Mission Viejo, California, United States
Synexus Clinical Research US Inc. Santa Rosa
Santa Rosa, California, United States
Olympian Clinical Research
Largo, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
Well Pharma Medical Research Corporation
South Miami, Florida, United States
Forward Clinical Trials Inc
Tampa, Florida, United States
Clinical Research Atlanta - ERN - PPDS
Stockbridge, Georgia, United States
Northwest Clinical Trials Clinedge
Boise, Idaho, United States
Randall Dermatology
West Lafayette, Indiana, United States
Derm Research LLC
Louisville, Kentucky, United States
Dermatology Specialists PSC
Louisville, Kentucky, United States
Michael W Simon MD Office
Nicholasville, Kentucky, United States
Delricht Clinical Research - Clinedge - PPDS Baton Rouge
Baton Rouge, Louisiana, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Jubilee Clinical Research - BTC - PPDS
Las Vegas, Nevada, United States
ActivMed Practices & Research Inc
Portsmouth, New Hampshire, United States
Hassman Research Institute
Berlin, New Jersey, United States
Skin Laser and Surgery specialists of New York and New Jersey LLC
Hackensack, New Jersey, United States
Derm Research Center Of New York Inc
Stony Brook, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, United States
International Clinical Research Tennessee LLC
Murfreesboro, Tennessee, United States
Epiphany Dermatology Fort Worth
Fort Worth, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Tanner Clinic
Layton, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
PI Coor Clinical Research LLC
Burke, Virginia, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Medical Center Unimed EOOD
Sevlievo, Gabrovo, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, , Bulgaria
Diagnostic Consultative Center XXVIII - Sofia - EOOD
Sofia, , Bulgaria
Synexus - Medical Center Synexus Sofia EOOD
Sofia, , Bulgaria
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
Stara Zagora, , Bulgaria
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
The Centre For Clinical Trials Inc.
Oakville, , Canada
Dermatology Ottawa Research Centre
Ottawa, , Canada
Dermamedica, s.r.o. - Kozni Ambulance Nachod
Náchod, , Czechia
CTCenter MaVe s.r.o.
Olomouc, , Czechia
CCR Ostrava, s.r.o.
Ostrava, , Czechia
Synexus Affiliate - CLINTRIAL s.r.o.
Prague, , Czechia
Synexus Czech s.r.o.
Prague, , Czechia
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Hautarztpraxis Mahlow
Brandenburg, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Centrum Medyczne Matusiak
Wroclaw, Lower Silesian Voivodeship, Poland
Synexus Affiliate - Bialystok - ClinicMed Daniluk, Nowak Spółka Jawna
Bialystok, , Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, , Poland
Synexus - Gdynia
Gdynia, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Synexus Affiliate - Krakowskie Centrum Medyczne
Krakow, , Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, , Poland
Synexus - Warsaw
Warsaw, , Poland
EMC Instytut Medyczny S.A.
Wroclaw, , Poland
Wro Medica
Wroclaw, , Poland
Hospital de Manises
Manises, Valencia, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
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.
Simpson EL, Kircik L, Blauvelt A, Kallender H, Sturm D, Wang M, Eichenfield LF. Ruxolitinib Cream in Adolescents/Adults with Atopic Dermatitis Meeting Severity Thresholds for Systemic Therapy: Exploratory Analysis of Pooled Results from Two Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2139-2151. doi: 10.1007/s13555-024-01219-8. Epub 2024 Jul 12.
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.
Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Forman SB, Kuligowski ME, Kallender H, Sun K, Ren H, Simpson EL. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. J Am Acad Dermatol. 2023 May;88(5):1008-1016. doi: 10.1016/j.jaad.2022.09.060. Epub 2022 Nov 26.
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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2018-003713-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-304
Identifier Type: -
Identifier Source: org_study_id
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