Clinical trial NCT05456529: Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
Official title: A Phase 3, Open-Label, One-Year Safety Study of Ruxolitinib Cream in Adolescents (Ages ≥ 12 Years to < 18 Years) With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis (AD)
Keywords: atopic dermatitis (AD)
adolescents
pruritus
eczema
topical therapy
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 103
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Detailed description: The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.
* Duration of AD of at least 2 years.
* Total IGA score of 2 to 3 at the screening and baseline visits.
* Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.
* Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.
* Agree to discontinue all agents used to treat AD from screening through the final follow up visit.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* An 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
* Any current and/or history of serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example:
* Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure \> 150/90 mm Hg) unless approved by the medical monitor/sponsor.
* Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.
* Current and/or history of arterial or venous thrombosis, including DVT and PE.
* Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.
* Any of the following clinical laboratory test results at screening:

  1. Hemoglobin \< 100 g/L (\< 10 g/dL)
  2. Liver function tests:
* AST or ALT ≥ 2.5 × ULN
* Total bilirubin \> 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation).

  d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
* Use of any of the following treatments within the indicated washout period before baseline:

  1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
  2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
  3. 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).

     Note: Live-attenuated vaccines are not recommended during the CT period. Note: COVID-19 vaccination is allowed.
  4. 1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), 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 and their frequency remains the same throughout the study.

* Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
* 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.
* 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.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor.
* Inability to draw blood for PK analysis from any nonlesional areas.
* Known allergy or reaction to any component of the study cream formulation.
* In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations.

Further exclusion criteria may apply.

Primary outcomes:
measure: Number of Treatment-emergent adverse events (TEAEs)
timeFrame: Baseline up to 56 weeks
Secondary outcomes:
measure: Number of participants with clinically notable vital sign changes from baseline
timeFrame: Baseline up to week 52
measure: Number of participants with clinically significant changes from Baseline in height
timeFrame: Baseline up to week 52
measure: Number of participants with clinically significant changes from Baseline in weight
timeFrame: Baseline up to week 52
measure: Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values
timeFrame: Baseline up to week 52
measure: Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
timeFrame: Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Pra
state: California
city: Westminster
country: United States
facility: Advanced Rx Clinical Research Group, Inc
state: California
city: Hollywood
country: United States
facility: Encore Medical Research, Llc Hollywood
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida, Llc
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: Columbus
country: United States
facility: Iact Health
state: Georgia
city: Normal
country: United States
facility: Sneeze Wheeze and Itch Associates Llc
state: Illinois
city: Skokie
country: United States
facility: Northshore University Health System
state: Illinois
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Omaha
country: United States
facility: Skin Specialists Pc the Advanced Skin Research Center
state: Nebraska
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: New York
country: United States
facility: Sadick Dermatology Sadick Research Group
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research Inc-Dublin
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
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: West Jordan
country: United States
facility: Jordan Valley Medical Center
state: Utah
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-Ho Hong Medical Inc.
state: British Columbia
city: London
country: Canada
facility: Lmc Manna Research (London)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: Xlr8 Medical Research
state: Ontario
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Dr. Zdybski
city: Warsaw
country: Poland
facility: Klinika Ambroziak
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
Study officials:
affiliation: Incyte Corporation
name: Brett Angel, MD
role: STUDY_DIRECTOR
References: