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

NCT03745638 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB 18424-3032018-003712-45
• Study Type: interventional
• Target: 631
• Locations: 7 countries
• Sites: 79

Brief Summary

The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Pruritus; Eczema; Topical Therapy; JAK Inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8

  The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥ 2 grade improvement from Baseline.

  Baseline to Week 8

Secondary Outcomes (40)

• VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75)

  Baseline to Week 8

• VC Period: Percentage of Participants With a ≥ 4-Point Improvement in Itch Numerical Rating Scale (NRS) Score

  Baseline to Week 8

• VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b - 24-Hour Recall) Score

  Baseline to Week 8

• VC Period: Percentage of Participants With a Clinically Meaningful (≥ 6-Point) Improvement in the PROMIS Short Form - Sleep-Related Impairment (8a - 24-Hour Recall)

  Baseline to Week 8

• VC Period: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (SAE)

  From first dose up to Week 8

Study Arms (7)

VC Period: Vehicle Cream BID

PLACEBO COMPARATOR

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.

Drug: Vehicle Cream

VC Period: Ruxolitinib 0.75% Cream BID

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

VC Period: Ruxolitinib 1.5% Cream BID

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

LTS Period: Ruxolitinib 0.75% Cream

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

LTS Period: Ruxolitinib 1.5% Cream

EXPERIMENTAL

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.

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Also known as: INCB018424 Phosphate Cream

LTS Period: Ruxolitinib 0.75% Cream; LTS Period: Ruxolitinib 1.5% Cream; LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID; LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID; VC Period: Ruxolitinib 0.75% Cream BID; VC Period: Ruxolitinib 1.5% Cream BID

Vehicle Cream DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

VC Period: Vehicle Cream BID

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents aged ≥12 to 17 years, inclusive, and men and women aged ≥18 years.
• 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.

You may not qualify if:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline.
• 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:
• half-lives or 12 weeks, whichever is longer - biologic agents (eg. dupilumab).
• weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg. mycophenolate or tacrolimus).
• weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (79)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dermatology Specialists Inc

Oceanside, California, 92056, United States

Location

Integrated Research Group Inc.

Riverside, California, 92506, United States

Location

Advanced Rx Clinical Research

Westminster, California, 92683, United States

Location

Clearlyderm Boca Raton - BTC - PPDS

Boca Raton, Florida, 33433, United States

Location

Olympian Clinical Research

Largo, Florida, 33770, United States

Location

Acevedo Clinical Research

Miami, Florida, 33142, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33143, United States

Location

AdvancedPharma CR LLC

Miami, Florida, 33147, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

ForCare Clinical Research

Tampa, Florida, 33624, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Aeroallergy Research Lab Of Savannah

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta - ERN-PPDS

Stockbridge, Georgia, 30281, United States

Location

Sneeze Wheeze and Itch Associates LLC

Normal, Illinois, 61761, United States

Location

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, 46256, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

Kansas City Dermatology P.A.

Overland Park, Kansas, 66215, United States

Location

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

Michael W Simon MD

Nicholasville, Kentucky, 40356, United States

Location

DermAssociates

Rockville, Maryland, 20850, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

Sadick Dermatology

New York, New York, 10075, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Ohio Pediatric Research Assn Inc

Huber Heights, Ohio, 45424, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Cyn3rgy Research - Clinedge - PPDS

Gresham, Oregon, 97030, United States

Location

Clinical Research Institute Of Southern Oregon - Crisor

Medford, Oregon, 97504, United States

Location

Oregon Medical Research Center PC

Portland, Oregon, 97223, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Synexus Clinical Research Us Inc. Greer

Greer, South Carolina, 29651, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Family Medicine Associates Of Texas

Carrollton, Texas, 75010, United States

Location

Progressive Clinical Research PA

San Antonio, Texas, 78213, United States

Location

Jordan Valley Medical Center

West Jordan, Utah, 84088, United States

Location

PI Coor Clinical Research LLC

Burke, Virginia, 22015, United States

Location

West End Dermatology

Henrico, Virginia, 23233, United States

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

York Dermatology Center

Richmond Hill, Ontario, L4C 9M7, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8X 3V6, Canada

Location

Siena Medical Reserch Corporation

Westmount, Quebec, H3Z 2S6, Canada

Location

CHRU de Brest - Hopital Morvan

Brest, 29609, France

Location

Le Bateau Blanc - Imm. A

Martigues, 13500, France

Location

Hôpital L'archet 2

Nice, 06202, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Elben Klinken Stade - Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Synexus (DRS) - Synexus Magyarország Kft. Budapest

Budapest, 1036, Hungary

Location

Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

Debrecen, 4025, Hungary

Location

Synexus (DRS) - Synexus Magyarország Kft. Gyula

Gyula, 5700, Hungary

Location

Pécsi Tudományegyetem

Pécs, 7632, Hungary

Location

Allergo-Derm Bakos Kft.

Szolnok, 5000, Hungary

Location

Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

Zalaegerszeg, 8900, Hungary

Location

Fondazione Policlinico Universitario A Gemelli

Roma, 168, Italy

Location

Synexus - Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

Centrum Medyczne ADAMAR

Wroclaw, Lower Silesian Voivodeship, 53-658, Poland

Location

ETG Zgierz

Zgierz, Lódzkie, 95-100, Poland

Location

Klinika Ambroziak

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Synexus - Gdansk

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Laser Clinic S.C.

Szczecin, West Pomeranian Voivodeship, 70-332, Poland

Location

Synexus - Katowice

Katowice, 40-040, Poland

Location

Centrum Medyczne Krakow - PRATIA - PPDS

Krakow, 30-510, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, 60-702, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

Tarnów, 33-100, Poland

Location

Medycyna Kliniczna Marzena Waszczak-Jeka

Warsaw, 00-874, Poland

Location

ETG Warszawa

Warsaw, 02-777, Poland

Location

Royalderm

Warsaw, 02-962, Poland

Location

Related Publications (7)

• 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.

  PMID: 39546129 DERIVED

• 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.

  PMID: 39375281 DERIVED

• 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.

  PMID: 38698175 DERIVED

• 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.

  PMID: 36264430 DERIVED

• 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.

  PMID: 33982267 DERIVED

• 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.

  PMID: 33957195 DERIVED

• 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.

  PMID: 33658996 DERIVED

Related Links

• Plain Language Summary of Results

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Michael E. Kuligowski, MD, PhD, MBA

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: December 20, 2018
• Primary Completion: December 23, 2019
• Study Completion: December 1, 2020
• Last Updated: September 28, 2023
• Results First Posted: December 17, 2021

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (5); HU (6); PL (14); CA (6); US (42); FR (5)