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Clinical Trial Details for TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis


Incyte Corporation
NCT ID: NCT03745651
Last Updated: May 24, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 12 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Incyte Corporation
  • Location: Not Provided

Official Title

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

Purpose

The purpose of this study is to assess the efficacy and safety of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

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

– Participants diagnosed with AD as defined by the Hanifin and Rajka criteria.

– AD duration of at least 2 years.

– Participants with an IGA score of 2 to 3 at screening and baseline (VC period) and 0
to 4 at Week 8 (long-term safety period).

– Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening
and baseline (VC period) and 0% to 20% at Week 8 (long-term safety 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:

– 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:

– 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 JAK inhibitors, systemic or topical.

– Ultraviolet 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 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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Incyte Corporation

Investigators

Study Director: Michael E. Kuligowski, MD, PhD, MBA

Incyte Corporation

Please refer to this study by its ClinicalTrials.gov identifier: NCT03745651

Location

Contacts

University Of Alabama At Birmingham

Birmingham, Alabama 35233

United States

Center For Dermatology Cosmetic And Laser Surgery

Fremont, California 94538

United States

Marvel Clinical Research - Clinedge - PPDS

Huntington Beach, California 92647

United States

Allergy And Asthma Associates Of Southern California - CRN

Mission Viejo, California 92691

United States

Synexus Clinical Research US Inc. Santa Rosa

Santa Rosa, California 95405

United States

Olympian Clinical Research

Largo, Florida 33770

United States

San Marcus Research Clinic Inc

Miami Lakes, Florida 33014

United States

Well Pharma Medical Research Corporation

South Miami, Florida 33143

United States

Forward Clinical Trials Inc

Tampa, Florida 33624

United States

Clinical Research Atlanta - ERN - PPDS

Stockbridge, Georgia 30281

United States

Northwest Clinical Trials Clinedge

Boise, Idaho 83704

United States

Derm Research LLC

Louisville, Kentucky 40217

United States

Dermatology Specialists PSC

Louisville, Kentucky 40241

United States

Michael W Simon MD Office

Nicholasville, Kentucky 40356

United States

Delricht Clinical Research - Clinedge - PPDS Baton Rouge

Baton Rouge, Louisiana 70809

United States

Hamzavi Dermatology

Fort Gratiot, Michigan 48059

United States

Jubilee Clinical Research - BTC - PPDS

Las Vegas, Nevada 89106

United States

ActivMed Practices & Research Inc

Portsmouth, New Hampshire 03801

United States

Hassman Research Institute

Berlin, New Jersey 08009

United States

Derm Research Center Of New York Inc

Stony Brook, New York 11790

United States

Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio 45236

United States

Ohio Pediatric Research Association

Dayton, Ohio 45414

United States

Paddington Testing Company Inc

Philadelphia, Pennsylvania 19103

United States

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina 29621

United States

International Clinical Research Tennessee LLC

Murfreesboro, Tennessee 37130

United States

Epiphany Dermatology Fort Worth

Fort Worth, Texas 76244

United States

Center for Clinical Studies

Webster, Texas 77598

United States

Tanner Clinic

Layton, Utah 84041

United States

Advanced Research Institute

Ogden, Utah 84405

United States

PI Coor Clinical Research LLC

Burke, Virginia 22015

United States

Clinical Research Partners LLC

Richmond, Virginia 23220

United States

Dermatology Specialists of Spokane

Spokane, Washington 99202

United States

The Centre For Clinical Trials Inc.

Oakville, L617W5

Canada

Dermatology Ottawa Research Centre

Ottawa, K2C 3N2

Canada