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

NCT ID: NCT04921969

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2024-04-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ruxolitinib (1.5% Cream)

Study drug will be administered twice daiily.

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

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

Ruxolitinib (0.75% cream)

Study drug will be administered twice daily.

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: DRUG

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

Vehicle Cream

Vehicle cream will be administered twice daily.

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

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

Interventions

Ruxolitinib

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

Intervention Type: DRUG

Vehicle Cream

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

Intervention Type: DRUG

Other Intervention Names

Jakafi; Placebo

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. Immunocompromised

2. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.

3. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.

4. 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.

5. 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.

6. Other types of eczema.

7. 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:

1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).

2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).

3. 2 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.

4. 1 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.

• Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit 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 HIV antibody.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
• In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
• Employees of the sponsor or investigator or otherwise dependents of them.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Angel, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Cahaba Dermatology

Hoover, Alabama, United States

Physicians Research Group Ii

Gilbert, Arizona, United States

Cct Research With Center For Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

First Oc Dermatology

Fountain Valley, California, United States

Iact Health

Los Angeles, California, United States

Metropolis Dermatology

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Madera Family Medical Group

Madera, California, United States

Allergy & Asthma Associates of Southern California

Mission Viejo, California, United States

Palmtree Clinical Research-Clinedge-Ppds

Palm Springs, California, United States

Integrated Research of Inland, Inc

Riverside, California, United States

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, United States

Phdermatology

Clearwater, Florida, United States

Life Clinical Trials Margate

Margate, Florida, United States

Acevedo Clinical Research

Miami, Florida, United States

Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc

Miami, Florida, United States

The Childrens Skin Center Csc Miami

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Ciocca Dermatology Pa

Miami, Florida, United States

Forcare Clinical Research

Tampa, Florida, United States

Aeroallergy Research Lab of Savannah

Savannah, Georgia, United States

Northwestern Memorial Hospital-Arkes Pavilion

Chicago, Illinois, United States

Sneeze Wheeze and Itch Associates Llc

Normal, Illinois, United States

Northshore Medical Group Dermatology Skokie

Skokie, Illinois, United States

Dermatology Specialists Research Indiana

Clarksville, Indiana, United States

Dawes Fretzin Clinical Research Group Llc

Indianapolis, Indiana, United States

Kansas City Dermatology P.A.

Lenexa, Kansas, United States

Office of Michael W. Simon, Md

Nicholasville, Kentucky, United States

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Delricht Clinical Research-Clinedge-Ppds Baton Rouge

Baton Rouge, Louisiana, United States

Delricht Research-Touro Medical Center

New Orleans, Louisiana, United States

Lawrence J. Green, Md. Llc

Rockville, Maryland, United States

Henry Ford Medical Center-New Center One

Detroit, Michigan, United States

Michigan Dermatology Institute

Waterford, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, United States

Dr Bobby Buka, Md Greenwich Village

New York, New York, United States

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

New York, New York, United States

Ohio Pediatric Research Association

Dayton, Ohio, United States

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

Grants Pass, Oregon, United States

Cyn3Rgy Research-Clinedge-Ppds

Gresham, Oregon, United States

Velocity Clinical Research-Medford

Medford, Oregon, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Knight Cancer Institute At Oregon Health and Science University

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Coastal Pediatric Associates

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Arlington Research Center

Arlington, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Texas Dermatology Alamo Heights Office

San Antonio, Texas, United States

Allergy and Asthma Care of Waco, Pa

Waco, Texas, United States

Intermountain Clinical Research Icr Draper

Draper, Utah, United States

Springville Dermatology

Springville, Utah, United States

Jordan Valley Dermatology Center

West Jordan, Utah, United States

Skindc Clinic

Arlington, Virginia, 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

Children'S Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Dermatology Research Institute

Calgary, Alberta, Canada

Leader Research

Hamilton, Ontario, Canada

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 18424-305

Identifier Type: -

Identifier Source: org_study_id