Atopic Dermatitis (AD)Phase 3NCT05456529
Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis
A Phase 3 study testing Ruxolitinib Cream in people with Atopic Dermatitis (AD), run by Incyte Corporation at 38 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Ruxolitinib Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 1 Sep 2022to 17 May 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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:
- Hemoglobin < 100 g/L (< 10 g/dL)
- 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).
- 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:
- 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
- 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
- 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.
- 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.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States26 sites
Arlington Research Center
Arlington, Texas, 76011
Meridian Clinical Research
Baton Rouge, Louisiana, 70808
Iact Health
Columbus, Georgia, 31904
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Aventiv Research Inc-Dublin
Dublin, Ohio, 43016
Empire Dermatology
East Syracuse, New York, 13057
First Oc Dermatology
Fountain Valley, California, 92708
Encore Medical Research, Llc Hollywood
Hollywood, Florida, 33021
Solutions Through Advanced Research, Inc
Jacksonville, Florida, 32256
Dermatology Research Associates
Los Angeles, California, 90045
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
Acevedo Clinical Research
Miami, Florida, 33142-2946
Skin Research of South Florida, Llc
Miami, Florida, 33173
Well Pharma Medical Research Corp.
Miami, Florida, 33173
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
Sadick Dermatology Sadick Research Group
New York, New York, 10075
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, 61761-6280
Arkansas Research Trials
North Little Rock, Arkansas, 72117
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska, 68144
Peninsula Research Associates Pra
Rolling Hills Estates, California, 90274
Progressive Clinical Research
San Antonio, Texas, 78213
Northshore University Health System
Skokie, Illinois, 60077
Forward Clinical Trials
Tampa, Florida, 33613
Jordan Valley Medical Center
West Jordan, Utah, 84088-8873
Advanced Rx Clinical Research Group, Inc
Westminster, California, 92683-4567
Canada6 sites
Dermatology Research Institute
Calgary, Alberta, T1Y 0B4
Lmc Manna Research (London)
London, Ontario, N6A 2C2
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Manna Research Toronto
Toronto, Ontario, M9W 4L6
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Xlr8 Medical Research
Windsor, Ontario, N8W 1E6
Poland6 sites
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-200
Centrum Medyczne Angelius Provita
Katowice, 40-611
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081
Dermedic Dr. Zdybski
Ostrowiec Świętokrzyski, 27-400
Centrum Medyczne Evimed
Warsaw, 02-625
Klinika Ambroziak
Warsaw, 02-953
About this study
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
The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).
Read the 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Ruxolitinib Cream
- Keywords
- atopic dermatitis (AD), adolescents, pruritus, eczema, topical therapy, JAK inhibitor
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Also called INCB18424 cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period. Receives: Drug: Ruxolitinib Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.
Measured: up to 462 days
Number of Participants With ≥Grade 3 TEAEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to 462 days
Secondary outcomes (29)
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10^9 cells per liter.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuk), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10^12/Liter.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Measured: up to Week 8
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10^9 cells per liter.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuko), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10^12/Liter.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Measured: from Week 9 up to Week 52 (44 weeks)
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) were measured in units per liter.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Measured: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2).
Measured: up to Week 8
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. ALT, ALP, AST, CK, and LDH were measured in units per liter.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Measured: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2).
Measured: from Week 9 up to Week 52 (44 weeks)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8, 44, and 52
Change From Baseline in Pulse at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8, 44, and 52
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8, 44, and 52
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8, 44, and 52
Change From Baseline in Height at Weeks 8 and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8 and 52
Change From Baseline in Weight at Weeks 8 and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 8 and 52
Plasma Concentration of Ruxolitinib
Blood samples were drawn to assess plasma concentration.
Measured: prior to study cream application at Weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Sep 2022
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Angel, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456529
- Sponsor's protocol ID
- INCB 18424-315
- Status last verified
- Jun 2025
- First submitted
- 8 Jul 2022
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Publications
Joyce JC, Hong HC, Siri DD, Toth D, Kallender H, Kuo Y, Stefani-Hunyady D, Papp KA. Safety and Tolerability of Ruxolitinib Cream in Adolescents with Mild-to-Moderate Atopic Dermatitis: Results From a 1-Year, Phase III, Open-Label Study. Am J Clin Dermatol. 2026 Jul;27(4):841-849. doi: 10.1007/s40257-026-01043-0. Epub 2026 May 27.
PubMed 42201487
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05456529
- Acronym / sponsor ID
- INCB 18424-315
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- atopic dermatitis (AD), adolescents, pruritus, eczema, topical therapy, JAK inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: Ruxolitinib CreamRuxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib CreamAlso: INCB18424 creamRuxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period. | Drug | Ruxolitinib |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 462 days
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.
Number of Participants With ≥Grade 3 TEAEs
Time frame: up to 462 days
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
29 secondary outcomes
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Time frame: up to Week 8
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Time frame: from Week 9 up to Week 52 (44 weeks)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Time frame: Baseline; Weeks 8, 44, and 52
Change From Baseline in Pulse at Weeks 8, 44, and 52
Time frame: Baseline; Weeks 8, 44, and 52
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Time frame: Baseline; Weeks 8, 44, and 52
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Time frame: Baseline; Weeks 8, 44, and 52
Change From Baseline in Height at Weeks 8 and 52
Time frame: Baseline; Weeks 8 and 52
Change From Baseline in Weight at Weeks 8 and 52
Time frame: Baseline; Weeks 8 and 52
Plasma Concentration of Ruxolitinib
Time frame: prior to study cream application at Weeks 2 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42201487Joyce JC, Hong HC, Siri DD, Toth D, Kallender H, Kuo Y, Stefani-Hunyady D, Papp KA. Safety and Tolerability of Ruxolitinib Cream in Adolescents with Mild-to-Moderate Atopic Dermatitis: Results From a 1-Year, Phase III, Open-Label Study. Am J Clin Dermatol. 2026 Jul;27(4):841-849. doi: 10.1007/s40257-026-01043-0. Epub 2026 May 27.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Angel, MD study director
Incyte Corporation
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib Cream in people with Atopic Dermatitis (AD), run by Incyte Corporation at 38 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: up to 462 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05456529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.