Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
- Registration Number
- NCT05456529
- Lead Sponsor
- Incyte Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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.
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An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
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Concurrent conditions and history of other diseases
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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:
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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.
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Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.
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Current and/or history of arterial or venous thrombosis, including DVT and PE.
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Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.
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Any of the following clinical laboratory test results at screening:
- Hemoglobin < 100 g/L (< 10 g/dL)
- Liver function tests:
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AST or ALT โฅ 2.5 ร ULN
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Total bilirubin > 1.5 ร 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.
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Use of any of the following treatments within the indicated washout period before baseline:
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5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
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4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
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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.
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1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveenoยฎ 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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ruxolitinib Ruxolitinib Cream Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
- Primary Outcome Measures
Name Time Method Number of Treatment-emergent adverse events (TEAEs) Baseline up to 56 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.
- Secondary Outcome Measures
Name Time Method Number of participants with clinically notable vital sign changes from baseline Baseline up to week 52 Changes in vital signs assessment of blood pressure, pulse, respiration rate, and body temperature.
Number of participants with clinically significant changes from Baseline in height Baseline up to week 52 Changes in height will be assessed.
Number of participants with clinically significant changes from Baseline in weight Baseline up to week 52 Changes in weight will be assessed.
Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values Baseline up to week 52 Laboratory test values outside the normal range will be assessed for severity based on the normal ranges for the clinical reference laboratory.
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52) Trough concentration is defined as drug concentration in blood and/or saliva sampling.
Trial Locations
- Locations (38)
Arlington Research Center
๐บ๐ธArlington, Texas, United States
First Oc Dermatology
๐บ๐ธFountain Valley, California, United States
Dermatology Research Associates
๐บ๐ธLos Angeles, California, United States
Peninsula Research Associates Pra
๐บ๐ธRolling Hills Estates, California, United States
Advanced Rx Clinical Research Group, Inc
๐บ๐ธWestminster, California, United States
Encore Medical Research, Llc Hollywood
๐บ๐ธHollywood, Florida, United States
Solutions Through Advanced Research, Inc
๐บ๐ธJacksonville, Florida, United States
Iact Health
๐บ๐ธColumbus, Georgia, United States
Sneeze Wheeze and Itch Associates Llc
๐บ๐ธNormal, Illinois, United States
Northshore University Health System
๐บ๐ธSkokie, Illinois, United States
Empire Dermatology
๐บ๐ธEast Syracuse, New York, United States
Sadick Dermatology Sadick Research Group
๐บ๐ธNew York, New York, United States
Ohio Pediatric Research Association
๐บ๐ธDayton, Ohio, United States
Aventiv Research Inc-Dublin
๐บ๐ธDublin, Ohio, United States
Apex Clinical Research Center
๐บ๐ธMayfield Heights, Ohio, United States
International Clinical Research Tennessee Llc
๐บ๐ธMurfreesboro, Tennessee, United States
Jordan Valley Medical Center
๐บ๐ธWest Jordan, Utah, United States
Lmc Manna Research (London)
๐จ๐ฆLondon, Ontario, Canada
Manna Research Toronto
๐จ๐ฆToronto, Ontario, Canada
Centrum Medyczne Pratia Czestochowa
๐ต๐ฑCzestochowa, Poland
K. Papp Clinical Research
๐จ๐ฆWaterloo, Ontario, Canada
Xlr8 Medical Research
๐จ๐ฆWindsor, Ontario, Canada
Centrum Medyczne Angelius Provita
๐ต๐ฑKatowice, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
๐ต๐ฑLublin, Poland
Dermedic Dr. Zdybski
๐ต๐ฑOstrowiec Swietokrzyski, Poland
Klinika Ambroziak
๐ต๐ฑWarsaw, Poland
Meridian Clinical Research
๐บ๐ธBaton Rouge, Louisiana, United States
Arkansas Research Trials
๐บ๐ธNorth Little Rock, Arkansas, United States
Dermatology Research Institute
๐จ๐ฆCalgary, Alberta, Canada
Centrum Medyczne Evimed
๐ต๐ฑWarszawa, Poland
Dr. Chih-Ho Hong Medical Inc.
๐จ๐ฆSurrey, British Columbia, Canada
Acevedo Clinical Research
๐บ๐ธMiami, Florida, United States
Skin Research of South Florida, Llc
๐บ๐ธMiami, Florida, United States
Well Pharma Medical Research Corp.
๐บ๐ธMiami, Florida, United States
Forward Clinical Trials
๐บ๐ธTampa, Florida, United States
Skin Specialists Pc the Advanced Skin Research Center
๐บ๐ธOmaha, Nebraska, United States
Lynn Health Science Institute
๐บ๐ธOklahoma City, Oklahoma, United States
Progressive Clinical Research
๐บ๐ธSan Antonio, Texas, United States