Atopic DermatitisPhase 3NCT04921969
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
A Phase 3 study testing Ruxolitinib in people with Atopic Dermatitis, run by Incyte Corporation at 67 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ruxolitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 67 sitesin 2 countries
- Study dates
- 19 Jul 2021to 8 Apr 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
- Immunocompromised
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
- Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
- 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.
Show all 20Show fewer
- 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.
- Other types of eczema.
- 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:
- 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
- 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
- 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.
- 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.
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States64 sites
Arlington Research Center
Arlington, Texas, 76011
Skindc Clinic
Arlington, Virginia, 22209
Meridian Clinical Research
Baton Rouge, Louisiana, 70808
Delricht Clinical Research-Clinedge-Ppds Baton Rouge
Baton Rouge, Louisiana, 70809
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Pi Coor Clinical Research Llc
Burke, Virginia, 22015
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital-Arkes Pavilion
Chicago, Illinois, 60611
Dermatology Specialists Research Indiana
Clarksville, Indiana, 47129
Phdermatology
Clearwater, Florida, 33756
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Henry Ford Medical Center-New Center One
Detroit, Michigan, 48202
Intermountain Clinical Research Icr Draper
Draper, Utah, 84020
First Oc Dermatology
Fountain Valley, California, 92708
Physicians Research Group Ii
Gilbert, Arizona, 85295
Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc
Grants Pass, Oregon, 97527
Cyn3Rgy Research-Clinedge-Ppds
Gresham, Oregon, 97030
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Cahaba Dermatology
Hoover, Alabama, 35244
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, 46250
Kansas City Dermatology P.A.
Lenexa, Kansas, 66215
Iact Health
Los Angeles, California, 90017
Metropolis Dermatology
Los Angeles, California, 90017
University of Southern California
Los Angeles, California, 90033
Dermatology Research Associates
Los Angeles, California, 90045
Madera Family Medical Group
Madera, California, 93637
Life Clinical Trials Margate
Margate, Florida, 33063
Velocity Clinical Research-Medford
Medford, Oregon, 97504
Acevedo Clinical Research
Miami, Florida, 33142
Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc
Miami, Florida, 33146
The Childrens Skin Center Csc Miami
Miami, Florida, 33155
Entrust Clinical Research
Miami, Florida, 33156
Ciocca Dermatology Pa
Miami, Florida, 33173
Children'S Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
Delricht Research-Touro Medical Center
New Orleans, Louisiana, 70115
Dr Bobby Buka, Md Greenwich Village
New York, New York, 10012
New York University Langone Medical Center-Fink Children'S Ambulatory Care Center
New York, New York, 10016
Office of Michael W. Simon, Md
Nicholasville, Kentucky, 40356
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, 61761
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska, 68144
Palmtree Clinical Research-Clinedge-Ppds
Palm Springs, California, 92262
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Clinical Research Partners Llc
Richmond, Virginia, 23220
Integrated Research of Inland, Inc
Riverside, California, 92506
Mayo Clinic
Rochester, Minnesota, 55905
Lawrence J. Green, Md. Llc
Rockville, Maryland, 20850
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology Alamo Heights Office
San Antonio, Texas, 78218
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, 90404
Aeroallergy Research Lab of Savannah
Savannah, Georgia, 31406
Cct Research With Center For Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260
Northshore Medical Group Dermatology Skokie
Skokie, Illinois, 60076
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Springville Dermatology
Springville, Utah, 84663
Forcare Clinical Research
Tampa, Florida, 33624
Allergy and Asthma Care of Waco, Pa
Waco, Texas, 76712
Michigan Dermatology Institute
Waterford, Michigan, 48328
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
Canada3 sites
Dermatology Research Institute
Calgary, Alberta, T3A 2N1
Leader Research
Hamilton, Ontario, L8L 3C3
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2
About this study
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)
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%).
- Conditions
- Atopic Dermatitis
- Being tested
- Ruxolitinib, Vehicle Cream
- Keywords
- Atopic Dermatitis, Ruxolitinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi
The study cream will be applied topically twice a day for up to 52 weeks.
Vehicle CreamDrug
Also called Placebo
Matching vehicle cream will be applied topically twice a day for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib (1.5% Cream) | Experimental | Study drug will be administered twice daiily. Receives: Drug: Ruxolitinib |
| Ruxolitinib (0.75% cream) | Experimental | Study drug will be administered twice daily. Receives: Drug: Ruxolitinib |
| Vehicle Cream | Placebo comparator | Vehicle cream will be administered twice daily. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Measured: Baseline to Week 8
Secondary outcomes (11)
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Measured: Baseline to Week 8
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Measured: Baseline to Day 7 (Week 1)
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting the number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Measured: Baseline to Day 3
VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event 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 is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Measured: from Baseline up to Week 8
LTS Period: Number of Participants With Any TEAE
An adverse event 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 is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Measured: From Week 8 up to Week 56
VC Period: Number of Participants With Any Grade 3 or Higher TEAE
A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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: from Baseline up to Week 8
LTS Period: Number of Participants With Any Grade 3 or Higher TEAE
A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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: From Week 12 up to Week 56
VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
Measured: Baseline to Weeks 2 and 4
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity using a diary. Participants were asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours.
Measured: Baseline to Weeks 2 and 4
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of ≥8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l), each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.
Measured: Baseline to Weeks 2, 4, and 8
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
The Itch NRS is a daily participant-reported measure (24-hour recall), of the worst level of itch intensity using a diary. Participants are asked to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. Kaplan-Meier estimation method was used for analyses.
Measured: up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start19 Jul 2021
- Primary completion10 May 2023
- Study completion8 Apr 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 DermatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 330 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
- NCT04921969
- Sponsor's protocol ID
- INCB 18424-305
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2021
- Last updated
- 28 Mar 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
Eichenfield LF, Stein Gold LF, Simpson EL, Zaenglein AL, Armstrong AW, Tollefson MM, Soong W, Wine Lee L, Devani AR, Forman SB, Siri DD, Kallender H, Angel B, Li Q, Chen X, Paller AS. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025 Sep;93(3):689-698. doi: 10.1016/j.jaad.2025.05.1385. Epub 2025 May 14.
PubMed 40378883
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04921969
- Acronym / sponsor ID
- INCB 18424-305
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Ruxolitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Posted 10 Jun 2024
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 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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib (1.5% Cream) | Experimental | Drug: RuxolitinibStudy drug will be administered twice daiily. |
| Ruxolitinib (0.75% cream) | Experimental | Drug: RuxolitinibStudy drug will be administered twice daily. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamVehicle cream will be administered twice daily. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- 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:
- 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.-
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 |
|---|---|---|
| RuxolitinibAlso: JakafiThe study cream will be applied topically twice a day for up to 52 weeks. | Drug | Ruxolitinib (0.75% cream), Ruxolitinib (1.5% Cream) |
| Vehicle CreamAlso: PlaceboMatching vehicle cream will be applied topically twice a day for up to 8 weeks. | Drug | Vehicle Cream |
Primary outcome
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
Time frame: Baseline to Week 8
The IGA is an overall eczema severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting. The IGA-TS is defined as an IGA score of 0 (clear skin) or 1 (almost clear skin) with ≥2 grade improvement from Baseline.
11 secondary outcomes
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
Time frame: Baseline to Week 8
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)
Time frame: Baseline to Day 7 (Week 1)
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3
Time frame: Baseline to Day 3
VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: from Baseline up to Week 8
LTS Period: Number of Participants With Any TEAE
Time frame: From Week 8 up to Week 56
VC Period: Number of Participants With Any Grade 3 or Higher TEAE
Time frame: from Baseline up to Week 8
LTS Period: Number of Participants With Any Grade 3 or Higher TEAE
Time frame: From Week 12 up to Week 56
VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
Time frame: Baseline to Weeks 2 and 4
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
Time frame: Baseline to Weeks 2 and 4
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
Time frame: Baseline to Weeks 2, 4, and 8
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
Time frame: up to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40378883Eichenfield LF, Stein Gold LF, Simpson EL, Zaenglein AL, Armstrong AW, Tollefson MM, Soong W, Wine Lee L, Devani AR, Forman SB, Siri DD, Kallender H, Angel B, Li Q, Chen X, Paller AS. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025 Sep;93(3):689-698. doi: 10.1016/j.jaad.2025.05.1385. Epub 2025 May 14.
- 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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Atopic Dermatitis
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
67 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib in people with Atopic Dermatitis, run by Incyte Corporation at 67 sites in 2 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 8 inclusion and 20 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 10 Jun 2024). 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?
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (time frame: Baseline to Week 8). 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 NCT04921969, 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 28 Mar 2025.