A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

NCT04921969 | Completed Phase 3 Results FDA Drug

• 1 other identifier: INCB 18424-305
• Study Type: interventional
• Target: 330
• Locations: 2 countries
• Sites: 67

Brief Summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Ruxolitinib

Outcome Measures

Primary Outcomes (1)

• VC Period: 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 (11)

• VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8

  Baseline to Week 8

• VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)

  Baseline to Day 7 (Week 1)

• VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3

  Baseline to Day 3

• VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  from Baseline up to Week 8

• LTS Period: Number of Participants With Any TEAE

  From Week 8 up to Week 56

Study Arms (3)

Ruxolitinib (1.5% Cream)

EXPERIMENTAL

Study drug will be administered twice daiily.

Drug: Ruxolitinib

Ruxolitinib (0.75% cream)

EXPERIMENTAL

Study drug will be administered twice daily.

Drug: Ruxolitinib

Vehicle Cream

PLACEBO COMPARATOR

Vehicle cream will be administered twice daily.

Drug: Vehicle Cream

Interventions

Ruxolitinib DRUG

The study cream will be applied topically twice a day for up to 52 weeks.

Also known as: Jakafi

Ruxolitinib (0.75% cream); Ruxolitinib (1.5% Cream)

Vehicle Cream DRUG

Matching vehicle cream will be applied topically twice a day for up to 8 weeks.

Also known as: Placebo

Vehicle Cream

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
• Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
• Participants with IGA score of 2 to 3 at the screening and baseline visits.
• Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
• For children aged 6 years to \< 12 years, baseline itch NRS score ≥ 4.
• Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
• Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
• Willingness to avoid pregnancy or fathering a child for the duration of study participation.

You may not qualify if:

• An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
• Concurrent conditions and history of other diseases as follows:
• Immunocompromised
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
• Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
• 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 classic areas of involvement such as the face or the flexural folds.
• Other types of eczema.
• Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
• 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 the baseline visit:
• half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
• weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
• weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.
• week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (67)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

Cahaba Dermatology

Hoover, Alabama, 35244, United States

Location

Physicians Research Group Ii

Gilbert, Arizona, 85295, United States

Location

Cct Research With Center For Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Iact Health

Los Angeles, California, 90017, United States

Location

Metropolis Dermatology

Los Angeles, California, 90017, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Palmtree Clinical Research-Clinedge-Ppds

Palm Springs, California, 92262, United States

Location

Integrated Research of Inland, Inc

Riverside, California, 92506, United States

Location

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, 90404, United States

Location

Phdermatology

Clearwater, Florida, 33756, United States

Location

Life Clinical Trials Margate

Margate, Florida, 33063, United States

Location

Acevedo Clinical Research

Miami, Florida, 33142, United States

Location

Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc

Miami, Florida, 33146, United States

Location

The Childrens Skin Center Csc Miami

Miami, Florida, 33155, United States

Location

Entrust Clinical Research

Miami, Florida, 33156, United States

Location

Ciocca Dermatology Pa

Miami, Florida, 33173, United States

Location

Forcare Clinical Research

Tampa, Florida, 33624, United States

Location

Aeroallergy Research Lab of Savannah

Savannah, Georgia, 31406, United States

Location

Northwestern Memorial Hospital-Arkes Pavilion

Chicago, Illinois, 60611, United States

Location

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, 61761, United States

Location

Northshore Medical Group Dermatology Skokie

Skokie, Illinois, 60076, United States

Location

Dermatology Specialists Research Indiana

Clarksville, Indiana, 47129, United States

Location

Dawes Fretzin Clinical Research Group Llc

Indianapolis, Indiana, 46250, United States

Location

Kansas City Dermatology P.A.

Lenexa, Kansas, 66215, United States

Location

Office of Michael W. Simon, Md

Nicholasville, Kentucky, 40356, United States

Location

Meridian Clinical Research

Baton Rouge, Louisiana, 70808, United States

Location

Delricht Clinical Research-Clinedge-Ppds Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Delricht Research-Touro Medical Center

New Orleans, Louisiana, 70115, United States

Location

Lawrence J. Green, Md. Llc

Rockville, Maryland, 20850, United States

Location

Henry Ford Medical Center-New Center One

Detroit, Michigan, 48202, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, 68144, United States

Location

Dr Bobby Buka, Md Greenwich Village

New York, New York, 10012, United States

Location

New York University Langone Medical Center-Fink Children'S Ambulatory Care Center

New York, New York, 10016, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc

Grants Pass, Oregon, 97527, United States

Location

Cyn3Rgy Research-Clinedge-Ppds

Gresham, Oregon, 97030, United States

Location

Velocity Clinical Research-Medford

Medford, Oregon, 97504, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Knight Cancer Institute At Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology Alamo Heights Office

San Antonio, Texas, 78218, United States

Location

Allergy and Asthma Care of Waco, Pa

Waco, Texas, 76712, United States

Location

Intermountain Clinical Research Icr Draper

Draper, Utah, 84020, United States

Location

Springville Dermatology

Springville, Utah, 84663, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

Skindc Clinic

Arlington, Virginia, 22209, United States

Location

Pi Coor Clinical Research Llc

Burke, Virginia, 22015, United States

Location

Clinical Research Partners Llc

Richmond, Virginia, 23220, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Children'S Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Dermatology Research Institute

Calgary, Alberta, T3A 2N1, Canada

Location

Leader Research

Hamilton, Ontario, L8L 3C3, Canada

Location

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

ruxolitinib

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

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Brett Angel, MD

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 10, 2021
• Study Start: July 19, 2021
• Primary Completion: May 10, 2023
• Study Completion: April 8, 2024
• Last Updated: March 28, 2025
• Results First Posted: June 10, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (64); CA (3)