Clinical trial NCT04921969: A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Ruxolitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 330
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).


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.

Primary outcomes:
measure: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)
timeFrame: Baseline to Day 7 (Week 1)
measure: VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3
timeFrame: Baseline to Day 3
measure: VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: from Baseline up to Week 8
measure: LTS Period: Number of Participants With Any TEAE
timeFrame: From Week 8 up to Week 56
measure: VC Period: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: from Baseline up to Week 8
measure: LTS Period: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: From Week 12 up to Week 56
measure: VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
timeFrame: Baseline to Weeks 2 and 4
measure: VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
timeFrame: Baseline to Weeks 2 and 4
measure: VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
timeFrame: Baseline to Weeks 2, 4, and 8
measure: VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
timeFrame: up to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Hoover
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Gilbert
country: United States
facility: Physicians Research Group Ii
state: Arizona
city: Scottsdale
country: United States
facility: Cct Research With Center For Dermatology and Plastic Surgery
state: Arizona
city: Hot Springs National Park
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Los Angeles
country: United States
facility: Iact Health
state: California
city: Los Angeles
country: United States
facility: Metropolis Dermatology
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research-Clinedge-Ppds
state: California
city: Riverside
country: United States
facility: Integrated Research of Inland, Inc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Clinical Research Specialists Inc
state: California
city: Clearwater
country: United States
facility: Phdermatology
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials Margate
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research
state: Florida
city: Miami
country: United States
facility: Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc
state: Florida
city: Miami
country: United States
facility: The Childrens Skin Center Csc Miami
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Ciocca Dermatology Pa
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Lab of Savannah
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital-Arkes Pavilion
state: Illinois
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates Llc
state: Illinois
city: Skokie
country: United States
facility: Northshore Medical Group Dermatology Skokie
state: Illinois
city: Clarksville
country: United States
facility: Dermatology Specialists Research Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group Llc
state: Indiana
city: Lenexa
country: United States
facility: Kansas City Dermatology P.A.
state: Kansas
city: Nicholasville
country: United States
facility: Office of Michael W. Simon, Md
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Baton Rouge
country: United States
facility: Delricht Clinical Research-Clinedge-Ppds Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research-Touro Medical Center
state: Louisiana
city: Rockville
country: United States
facility: Lawrence J. Green, Md. Llc
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Medical Center-New Center One
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists Pc the Advanced Skin Research Center
state: Nebraska
city: New York
country: United States
facility: Dr Bobby Buka, Md Greenwich Village
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center-Fink Children'S Ambulatory Care Center
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Grants Pass
country: United States
facility: Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc
state: Oregon
city: Gresham
country: United States
facility: Cyn3Rgy Research-Clinedge-Ppds
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research-Medford
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Knight Cancer Institute At Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology Alamo Heights Office
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Care of Waco, Pa
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research Icr Draper
state: Utah
city: Springville
country: United States
facility: Springville Dermatology
state: Utah
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Arlington
country: United States
facility: Skindc Clinic
state: Virginia
city: Burke
country: United States
facility: Pi Coor Clinical Research Llc
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners Llc
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Milwaukee
country: United States
facility: Children'S Hospital of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Hamilton
country: Canada
facility: Leader Research
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
Study officials:
affiliation: Incyte Corporation
name: Brett Angel, MD
role: STUDY_DIRECTOR
References: