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History of Changes for Study: NCT03745638
TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
Latest version (submitted December 22, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 15, 2018 None (earliest Version on record)
2 December 5, 2018 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions and Oversight
3 May 23, 2019 Contacts/Locations and Study Status
4 November 1, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 January 2, 2020 Study Status
6 February 4, 2020 Study Status and Contacts/Locations
7 December 22, 2020 Recruitment Status, Study Status and Study Design
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Study NCT03745638
Submitted Date:  May 23, 2019 (v3)

Open or close this module Study Identification
Unique Protocol ID: INCB 18424-303
Brief Title: TRuE AD1 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2019
Overall Status: Recruiting
Study Start: November 28, 2018
Primary Completion: August 2020 [Anticipated]
Study Completion: September 2020 [Anticipated]
First Submitted: November 15, 2018
First Submitted that
Met QC Criteria:
November 15, 2018
First Posted: November 19, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 23, 2019
Last Update Posted: May 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Incyte Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).
Detailed Description:
Open or close this module Conditions
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
pruritus
eczema
topical therapy
JAK inhibitor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Ruxolitinib cream Drug: Ruxolitinib cream
Ruxolitinib cream 1.5% or 0.75% applied as a thin film twice daily (BID) (vehicle-controlled (VC) and long-term safety extension periods).
Other Names:
  • INCB018424 phosphate cream
Placebo Comparator: Vehicle cream Drug: Vehicle cream
Matching vehicle cream applied as a thin film BID (VC period only).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS)
[ Time Frame: From baseline up to 8 weeks ]

Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.
Secondary Outcome Measures:
1. Proportion of participants who achieve EASI75
[ Time Frame: Up to 8 weeks ]

Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.
2. Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score
[ Time Frame: Up to 8 weeks ]

3. Proportion of participants with a clinically meaningful improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form - Sleep Disturbance (8b) 24-hour recall score
[ Time Frame: Up to 8 weeks ]

4. Participants with treatment-emergent adverse events (TEAEs)
[ Time Frame: Up to 52 weeks ]

TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
5. Proportion of participants achieving an IGA-TS
[ Time Frame: From baseline up to 4 weeks ]

Defined as IGA score of 0 or 1 with ≥ 2 grade improvement from baseline.
6. Proportion of participants achieving an IGA of 0 or 1 at each visit
[ Time Frame: Up to 8 weeks ]

7. Proportion of participants with a ≥ 4 point improvement in Itch NRS score
[ Time Frame: Up to 4 weeks ]

8. Proportion of participants who achieve EASI50 at each visit during the VC period.
[ Time Frame: Up to 8 weeks ]

Defined as ≥50% improvement in EASI score.
9. Proportion of participants who achieve EASI75
[ Time Frame: Up to 4 weeks ]

Defined as ≥ 75% improvement in EASI score.
10. Proportion of participants who achieve EASI90 at each visit during the VC period
[ Time Frame: Up to 8 weeks ]

≥90% improvement in EASI score.
11. Mean percentage change from baseline in EASI score at each visit during the VC period
[ Time Frame: From baseline up to 8 weeks ]

12. Mean percentage change from baseline in SCORAD score at each visit during the VC period
[ Time Frame: From baseline up to 8 weeks ]

SCORing Atopic Dermatitis - tool used to assess extent and severity (intensity) of eczema.
13. Change from baseline in Itch NRS score at each visit during the VC period
[ Time Frame: From baseline up to 8 weeks ]

The Itch NRS is a daily patient-reported measure of the worst level of itch intensity. Participants will be asked to rate the itching severity by selecting a number from 0 (no itch) to 10 (worst imaginable itch).
14. Time to achieve Itch NRS score improvement of at least 2, 3, or 4 points
[ Time Frame: Up to 8 weeks ]

15. Change from baseline in Skin Pain NRS score at each visit during the VC period
[ Time Frame: From baseline up to 8 weeks ]

The Skin Pain NRS is a daily patient-reported measure of the worst level of pain intensity from 0 (no pain) to 10 (worst imaginable pain).
16. Proportion of participants with a clinically meaningful improvement in the PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score
[ Time Frame: Up to 8 weeks ]

17. Change from baseline in PROMIS Short Form - Sleep Related Impairment (8a) 24-hour recall and Short Form - Sleep Disturbance (8b) 24-hour recall score
[ Time Frame: From baseline up to 8 weeks ]

18. PROMIS Short Form - Sleep-Related Impairment (8a) 7-day recall and Short Form - Sleep Disturbance (8b) 7-day recall score
[ Time Frame: Up to 52 weeks ]

19. Change from baseline in AD afflicted percentage of body surface area (%BSA) at every visit
[ Time Frame: From baseline up to 52 weeks ]

20. Change from baseline in Patient-Oriented Eczema Measure (POEM) score at each visit
[ Time Frame: From baseline up to 52 weeks ]

The POEM is a 7-question quality-of-life assessment that asks how many days the participant has been bothered by various aspects of their skin condition during the past 7 days.
21. Change from baseline in Dermatology Life Quality Index (DLQI) score
[ Time Frame: From baseline up to 52 weeks ]

The DLQI is a 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The participant will answer the questionnaire with either (1) very much, (2) a lot, (3) a little, or (4) not at all.
22. Mean Patient Global Impression of Change (PGIC) score
[ Time Frame: Up to 8 weeks ]

The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
23. Proportion of participants with each score on the PGIC
[ Time Frame: Up to 8 weeks ]

The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
24. Proportion of participants with a score of either 1 or 2 on the PGIC
[ Time Frame: Up to 8 weeks ]

The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
25. Change from baseline in EQ-5D-5L score during the VC period
[ Time Frame: From baseline up to 8 weeks ]

EQ-5D is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The 5L indicates that for each dimension, there are 5 levels, which are as follows: no problems, slight problems, moderate problems, severe problems, and extreme problems.

The digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state.

26. Change from baseline in WPAI-SHP v2.0
[ Time Frame: From baseline up to 52 weeks ]

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Version 2.0.

The WPAI:SHP v2.0 questionnaire is a validated 6-item instrument, completed that measures the effect of overall health and specific symptoms on productivity at work and regular activities outside of work.

27. Trough plasma concentrations of ruxolitinib at all study visits
[ Time Frame: Up to 52 weeks ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Incyte Corporation Call Center (US)
Telephone: 1.855.463.3463
Email: medinfo@incyte.com
Central Contact Backup: Incyte Corporation Call Center (ex-US)
Telephone: +800 00027423
Email: globalmedinfo@incyte.com
Study Officials: Michael E. Kuligowski, MD, PhD, MBA
Study Director
Incyte Corporation
Locations: United States, Arizona
Elite Clinical Studies
[Recruiting]
Phoenix, Arizona, United States, 85018
Contact:Principal Investigator: Joseph Lillo
United States, Arkansas
Northwest Arkansas Clinical Trials Center PLLC
[Not yet recruiting]
Rogers, Arkansas, United States, 72758
Contact:Principal Investigator: Cheryl Hull
United States, California
First OC Dermatology
[Recruiting]
Fountain Valley, California, United States, 92708
Contact:Principal Investigator: Vivian Laquer
Dermatology Research Associates
[Not yet recruiting]
Los Angeles, California, United States, 90045
Contact:Principal Investigator: Howard Sofen
Dermatology Specialists Inc
[Recruiting]
Oceanside, California, United States, 92056
Contact:Principal Investigator: Joseph Samady
Stanford University
[Not yet recruiting]
Palo Alto, California, United States, 94304
Contact:Principal Investigator: Joyce Teng
Integrated Research Group Inc.
[Recruiting]
Riverside, California, United States, 92506
Contact:Principal Investigator: Amit Patel
Advanced Rx Clinical Research
[Recruiting]
Westminster, California, United States, 92683
Contact:Principal Investigator: Dinh Dinh
United States, Florida
Clearlyderm Boca Raton - BTC - PPDS
[Recruiting]
Boca Raton, Florida, United States, 33433
Contact:Principal Investigator: Andrea Colton
Olympian Clinical Research
[Recruiting]
Largo, Florida, United States, 33770
Contact:Principal Investigator: Giselle Torres-Bonilla
Acevedo Clinical Research
[Recruiting]
Miami, Florida, United States, 33142
Contact:Principal Investigator: Armando Acevedo
AdvancedPharma CR LLC
[Recruiting]
Miami, Florida, United States, 33147
Contact:Principal Investigator: Kimberly Cruz
Metabolic Research Institute Inc
[Recruiting]
West Palm Beach, Florida, United States, 33401
Contact:Principal Investigator: Barry Horowitz
United States, Georgia
Aeroallergy Research Lab Of Savannah
[Recruiting]
Savannah, Georgia, United States, 31406
Contact:Principal Investigator: Brad Goodman
United States, Illinois
Sneeze Wheeze and Itch Associates LLC
[Recruiting]
Normal, Illinois, United States, 61761
Contact:Principal Investigator: Dareen Siri
United States, Indiana
Dawes Fretzin Clinical Research Group LLC
[Recruiting]
Indianapolis, Indiana, United States, 46256
Contact:Principal Investigator: Scott Fretzin
DS Research
[Recruiting]
New Albany, Indiana, United States, 47150
Contact:Principal Investigator: Megan Landis
United States, Louisiana
Delricht Clinical Research LLC - Clinedge - PPDS
[Not yet recruiting]
New Orleans, Louisiana, United States, 70115
Contact:Principal Investigator: Deirdre Hooper
United States, Maryland
DermAssociates
[Recruiting]
Rockville, Maryland, United States, 20850
Contact:Principal Investigator: Benjamin Lockshin
United States, Nevada
JDR Dermatology Research
[Recruiting]
Las Vegas, Nevada, United States, 89148
Contact:Principal Investigator: James Del Rosso
United States, New York
Forest Hills Dermatology Group
[Recruiting]
Forest Hills, New York, United States, 11375
Contact:Principal Investigator: Jeffrey Weinberg
Sadick Dermatology
[Recruiting]
New York, New York, United States, 10075
Contact:Principal Investigator: Neil Sadick
United States, North Carolina
Wake Research Associates, LLC
[Recruiting]
Raleigh, North Carolina, United States, 27612
Contact:Principal Investigator: Adnan Nasir
United States, Oklahoma
Central Sooner Research
[Recruiting]
Norman, Oklahoma, United States, 73071
Contact:Principal Investigator: Paul Gillum
United States, Oregon
Cyn3rgy Research - Clinedge - PPDS
[Recruiting]
Gresham, Oregon, United States, 97030
Contact:Principal Investigator: Frank Calcagno
Clinical Research Institute Of Southern Oregon - Crisor
[Recruiting]
Medford, Oregon, United States, 97504
Contact:Principal Investigator: Edward Kerwin
United States, South Carolina
Synexus Clinical Research Us Inc. Greer
[Recruiting]
Greer, South Carolina, United States, 29651
Contact:Principal Investigator: John Humeniuk
United States, Texas
Family Medicine Associates Of Texas
[Recruiting]
Carrollton, Texas, United States, 75010
Contact:Principal Investigator: Jeffrey Stewart
United States, Utah
Jordan Valley Medical Center
[Recruiting]
West Jordan, Utah, United States, 84088
Contact:Principal Investigator: Douglass Forsha
United States, Virginia
West End Dermatology
[Recruiting]
Henrico, Virginia, United States, 23233
Contact:Principal Investigator: Yvonne Knight
Canada, Alberta
Institute for Skin Advancement
[Not yet recruiting]
Calgary, Alberta, Canada, T3A 2N1
Contact:Principal Investigator: Alim Devani
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
[Not yet recruiting]
Surrey, British Columbia, Canada, V3R 6A7
Contact:Principal Investigator: Chih-Ho Hong
Canada, Ontario
CCA Medical Research
[Not yet recruiting]
Ajax, Ontario, Canada, L15 7K8
Contact:Principal Investigator: David Adam
Lynderm Research Inc
[Recruiting]
Markham, Ontario, Canada, L3P 1X2
Contact:Principal Investigator: Charles Lynde
York Dermatology Center
[Recruiting]
Richmond Hill, Ontario, Canada, L4C 9M7
Contact:Principal Investigator: Afsaneh Alavi
K. Papp Clinical Research
[Recruiting]
Waterloo, Ontario, Canada, N2J 1C4
Contact:Principal Investigator: Kim Papp
Windsor Clinical Research Inc.
[Recruiting]
Windsor, Ontario, Canada, N8W 5L7
Contact:Principal Investigator: Jerry Tan
XLR8 Medical Research
[Recruiting]
Windsor, Ontario, Canada, N8X 3V6
Contact:Principal Investigator: Darryl Toth
Canada, Quebec
Siena Medical Reserch Corporation
[Recruiting]
Westmount, Quebec, Canada, H3Z 2S6
Contact:Principal Investigator: Wayne Carey
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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