Logo of National Eczema Association mobile menu icon
Icon link to National Eczema's Instagram feed. Icon link to National Eczema's YouTube channel. Icon link to National Eczema's Facebook page. Icon link to National Eczema's Twitter feed. Icon link to National Eczema's inspire.com page. Search Icon to search the site

Get the tools and support you need to best manage your eczema

  • This field is for validation purposes and should be left unchanged.

Clinical Trial Details for TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis


Incyte Corporation
NCT ID: NCT03745638
Last Updated: May 23, 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 1 (TRuE AD1) - 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: NCT03745638

Location

Contacts

Elite Clinical Studies

Phoenix, Arizona 85018

United States

Northwest Arkansas Clinical Trials Center PLLC

Rogers, Arkansas 72758

United States

First OC Dermatology

Fountain Valley, California 92708

United States

Dermatology Research Associates

Los Angeles, California 90045

United States

Dermatology Specialists Inc

Oceanside, California 92056

United States

Stanford University

Palo Alto, California 94304

United States

Integrated Research Group Inc.

Riverside, California 92506

United States

Advanced Rx Clinical Research

Westminster, California 92683

United States

Clearlyderm Boca Raton - BTC - PPDS

Boca Raton, Florida 33433

United States

Olympian Clinical Research

Largo, Florida 33770

United States

Acevedo Clinical Research

Miami, Florida 33142

United States

AdvancedPharma CR LLC

Miami, Florida 33147

United States

Metabolic Research Institute Inc

West Palm Beach, Florida 33401

United States

Aeroallergy Research Lab Of Savannah

Savannah, Georgia 31406

United States

Sneeze Wheeze and Itch Associates LLC

Normal, Illinois 61761

United States

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana 46256

United States

DS Research

New Albany, Indiana 47150

United States

Delricht Clinical Research LLC - Clinedge - PPDS

New Orleans, Louisiana 70115

United States

DermAssociates

Rockville, Maryland 20850

United States

JDR Dermatology Research

Las Vegas, Nevada 89148

United States

Forest Hills Dermatology Group

Forest Hills, New York 11375

United States

Sadick Dermatology

New York, New York 10075

United States

Wake Research Associates, LLC

Raleigh, North Carolina 27612

United States

Central Sooner Research

Norman, Oklahoma 73071

United States

Cyn3rgy Research - Clinedge - PPDS

Gresham, Oregon 97030

United States

Clinical Research Institute Of Southern Oregon - Crisor

Medford, Oregon 97504

United States

Synexus Clinical Research Us Inc. Greer

Greer, South Carolina 29651

United States

Family Medicine Associates Of Texas

Carrollton, Texas 75010

United States

Jordan Valley Medical Center

West Jordan, Utah 84088

United States

West End Dermatology

Henrico, Virginia 23233

United States

Institute for Skin Advancement

Calgary, Alberta T3A 2N1

Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia V3R 6A7

Canada

CCA Medical Research

Ajax, Ontario L15 7K8

Canada

Lynderm Research Inc

Markham, Ontario L3P 1X2

Canada

York Dermatology Center

Richmond Hill, Ontario L4C 9M7

Canada

K. Papp Clinical Research

Waterloo, Ontario N2J 1C4

Canada

Windsor Clinical Research Inc.

Windsor, Ontario N8W 5L7

Canada

XLR8 Medical Research

Windsor, Ontario N8X 3V6

Canada

Siena Medical Reserch Corporation

Westmount, Quebec H3Z 2S6

Canada