CompletedNCT04921969Updated Mar 28, 2025Results posted

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

A Phase 3 interventional study of Ruxolitinib and Vehicle Cream in Atopic Dermatitis, sponsored by Incyte Corporation. Completed at 67 sites in 2 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 330
Allocation: Randomized
Ages: 2 Years to 11 Years
Sex: All

Study summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Conditions studied

Atopic Dermatitis

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Keywords

Atopic Dermatitis
Ruxolitinib

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 330 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 11 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
Participants with IGA score of 2 to 3 at the screening and baseline visits.
Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
For children aged 6 years to \< 12 years, baseline itch NRS score ≥ 4.
Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
Willingness to avoid pregnancy or fathering a child for the duration of study participation.

Exclusion criteria

Exclusion Criteria:

An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.
Concurrent conditions and history of other diseases as follows:
1. Immunocompromised
2. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
3. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.
4. Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.
5. Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
6. Other types of eczema.
7. Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Use of any of the following treatments within the indicated washout period before the baseline visit:
1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).
2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).
3. 2 weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.
4. 1 week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week.
Participants who have previously received JAK inhibitors, systemic or topical. -Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.-
Positive serology test results at screening for HIV antibody.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
Employees of the sponsor or investigator or otherwise dependents of them.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 330 participants (actual)

Study arms

Experimental
Ruxolitinib (1.5% Cream)
Study drug will be administered twice daiily.
Drug: Ruxolitinib
Experimental
Ruxolitinib (0.75% cream)
Study drug will be administered twice daily.
Drug: Ruxolitinib
Placebo comparator
Vehicle Cream
Vehicle cream will be administered twice daily.
Drug: Vehicle Cream

Interventions

DrugRuxolitinib
The study cream will be applied topically twice a day for up to 52 weeks.
Also known as: Jakafi
DrugVehicle Cream
Matching vehicle cream will be applied topically twice a day for up to 8 weeks.
Also known as: Placebo

What researchers measure

Primary outcomes

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.
Time frame: Baseline to Week 8

Secondary outcomes

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.
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)
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: up to Week 8

Results

Posted Jun 10, 2024

Participant flow

A total of 330 participants were enrolled at 48 study centers in the United States and Canada.

VC Period (Day 1 to Week 8)

Participant flow — VC Period (Day 1 to Week 8)
Milestone	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Started	65	134	131
Completed	49	120	115
Not completed	16	14	16
Withdrew: Adverse event	0	1	1
Withdrew: Lack of efficacy	2	0	0
Withdrew: Lost to follow-up	2	5	5
Withdrew: Physician decision	0	1	1
Withdrew: Protocol violation	0	0	1
Withdrew: Withdrawal by subject	9	5	8
Withdrew: Protocol-specified withdrawal criterion met	3	2	0

LTS Period (Weeks 8 to 52)

Participant flow — LTS Period (Weeks 8 to 52)
Milestone	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream BID	LTS Period: Ruxolitinib 1.5% Cream BID
Started	25	24	119	114
Completed	18	15	71	77
Not completed	7	9	48	37
Withdrew: Adverse event	0	0	0	1
Withdrew: Lack of efficacy	1	0	3	2
Withdrew: Lost to follow-up	1	6	18	9
Withdrew: Physician decision	1	0	1	1
Withdrew: Withdrawal by subject	2	3	22	18
Withdrew: Protocol-specified withdrawal criterion met	1	0	1	2
Withdrew: Non-compliance with study drug	1	0	0	1
Withdrew: Follow-up not performed per protocol	0	0	3	3

Outcome measures

PrimaryVC 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.

Time frame:: Baseline to Week 8
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8	10.8 (4.4 to 20.9)	36.6 (28.4 to 45.3)	56.5 (47.6 to 65.1)

Statistical analysis

VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 0.75% Cream BID · Exact Logistic Regression · p = 0.0001 (The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.) · Odds ratio (or): 4.74 · 95% CI 1.951 to 13.315
VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 1.5% Cream BID · Exact Logistic Regression · p = <0.0001 (The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.) · Odds ratio (or): 10.72 · 95% CI 4.429 to 30.042

SecondaryVC 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.

Time frame:: Baseline to Week 8
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8	29.7 (15.873 to 46.980)	37.5 (26.919 to 49.035)	43.4 (32.083 to 55.288)

Statistical analysis

VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 0.75% Cream BID · Exact Logistic Regression · p = 0.4198 (The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.) · Odds ratio (or): 1.41 · 95% CI 0.610 to 3.268
VC Period: Vehicle Cream BID vs VC Period: Ruxolitinib 1.5% Cream BID · Exact Logistic Regression · p = 0.1685 (The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.) · Odds ratio (or): 1.80 · 95% CI 0.779 to 4.174

SecondaryVC 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)
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)	11.5	23.5	28.2

SecondaryVC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3

Time frame:: Baseline to Day 3
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3	4.1	14.6	12.1

SecondaryVC 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.

Time frame:: from Baseline up to Week 8
Reported as:: Count of participants · Participants

VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	18	35	48

SecondaryLTS Period: Number of Participants With Any TEAE

Time frame:: From Week 8 up to Week 56
Reported as:: Count of participants · Participants

LTS Period: Number of Participants With Any TEAE
Participants	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream BID	LTS Period: Ruxolitinib 1.5% Cream BID
LTS Period: Number of Participants With Any TEAE	9	13	57	63

SecondaryVC 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.

Time frame:: from Baseline up to Week 8
Reported as:: Count of participants · Participants

VC Period: Number of Participants With Any Grade 3 or Higher TEAE
Participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
VC Period: Number of Participants With Any Grade 3 or Higher TEAE	0	0	2

SecondaryLTS Period: Number of Participants With Any Grade 3 or Higher TEAE

Time frame:: From Week 12 up to Week 56
Reported as:: Count of participants · Participants

LTS Period: Number of Participants With Any Grade 3 or Higher TEAE
Participants	LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID	LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	LTS Period: Ruxolitinib 0.75% Cream BID	LTS Period: Ruxolitinib 1.5% Cream BID
LTS Period: Number of Participants With Any Grade 3 or Higher TEAE	0	0	3	3

SecondaryVC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4

Time frame:: Baseline to Weeks 2 and 4
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Week 2	4.6 (1.0 to 12.9)	24.6 (17.6 to 32.8)	35.1 (27.0 to 43.9)
Week 4	12.3 (5.5 to 22.8)	36.6 (28.4 to 45.3)	48.1 (39.3 to 57.0)

SecondaryVC 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.

Time frame:: Baseline to Weeks 2 and 4
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Week 2	8.1 (1.704 to 21.910)	23.8 (14.945 to 34.578)	23.7 (14.682 to 34.824)
Week 4	10.8 (3.025 to 25.418)	33.8 (23.553 to 45.191)	36.8 (26.058 to 48.686)

SecondaryVC 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.

Time frame:: Baseline to Weeks 2, 4, and 8
Reported as:: Number · percentage of participants

VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8
percentage of participants	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Week 2	6.2 (1.702 to 15.013)	35.8 (27.728 to 44.556)	43.5 (34.876 to 52.447)
Week 4	12.3 (5.466 to 22.819)	53.0 (44.178 to 61.658)	62.6 (53.718 to 70.890)
Week 8	15.4 (7.632 to 26.478)	51.5 (42.708 to 60.210)	67.2 (58.432 to 75.123)

SecondaryVC 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.

Time frame:: up to Week 8
Reported as:: Median · days

VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 Points
days	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID
Improvement of at least 2 points	6.0 (4.0 to 21.0)	4.0 (3.0 to 5.0)	5.0 (3.0 to 6.0)
Improvement of at least 4 points	23.0 (13.0 to NA)	11.0 (9.0 to 20.0)	13.0 (9.0 to 17.0)

Adverse events

Collected over up to 60 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Vehicle Cream BID	0/65 (0%)	0/65 (0%)	4/65 (6.2%)
Ruxolitinib 0.75% Cream BID	0/159 (0%)	0/159 (0%)	50/159 (31.4%)
Ruxolitinib 1.5% Cream BID	0/154 (0%)	3/154 (1.9%)	49/154 (31.8%)

Most frequent serious events

Most frequent serious events
Event	Vehicle Cream BID	Ruxolitinib 0.75% Cream BID	Ruxolitinib 1.5% Cream BID
AsthmaRespiratory, thoracic and mediastinal disorders	0/65	0/159	2/154
Eczema herpeticumInfections and infestations	0/65	0/159	1/154

Most frequent other events

Most frequent other events
Event	Vehicle Cream BID	Ruxolitinib 0.75% Cream BID	Ruxolitinib 1.5% Cream BID
Upper respiratory tract infectionInfections and infestations	2/65	22/159	23/154
NasopharyngitisInfections and infestations	1/65	9/159	20/154
COVID-19Infections and infestations	1/65	13/159	11/154
PyrexiaGeneral disorders	0/65	10/159	6/154
Pharyngitis streptococcalInfections and infestations	0/65	9/159	3/154

Baseline characteristics

Age, Continuous
Age, Continuous(years)	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
Mean	6.3 ± 3.12	6.6 ± 2.83	6.4 ± 2.94	6.5 ± 2.93

Sex: Female, Male
Sex: Female, Male(Participants)	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
Female	38	73	68	179
Male	27	61	63	151

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
White/Caucasian	37	75	68	180
Black/African-American	19	45	42	106
Asian	3	7	11	21
American-Indian/Alaska Native	0	0	1	1
Native Hawaiian/Pacific Islander	1	1	0	2
Not Reported	0	1	1	2
Black or African American and White	2	2	2	6
Mixed, Black	1	0	0	1
Captured as Hispanic or Latino in Database	2	0	2	4
Caucasian and North African	0	1	0	1
Caregiver Did Not Identify	0	1	0	1
Puerto Rican	0	1	0	1
Black and Asian	0	0	1	1
African-American/Black, Hispanic, and Caucasian/White	0	0	1	1
Portuguese	0	0	1	1
Brazilian	0	0	1	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	VC Period: Vehicle Cream BID	VC Period: Ruxolitinib 0.75% Cream BID	VC Period: Ruxolitinib 1.5% Cream BID	Total
Hispanic or Latino	26	32	42	100
Not Hispanic or Latino	39	99	89	227
Not Reported	0	1	0	1
Unknown	0	1	0	1
Asian	0	1	0	1

Study locations

67 sites

Clinical Research Center of Alabama
Birmingham, Alabama 35209, United States
Cahaba Dermatology
Hoover, Alabama 35244, United States
Physicians Research Group Ii
Gilbert, Arizona 85295, United States
Cct Research With Center For Dermatology and Plastic Surgery
Scottsdale, Arizona 85260, United States
Burke Pharmaceutical Research
Hot Springs National Park, Arkansas 71913, United States
First Oc Dermatology
Fountain Valley, California 92708, United States
Iact Health
Los Angeles, California 90017, United States
Metropolis Dermatology
Los Angeles, California 90017, United States
University of Southern California
Los Angeles, California 90033, United States
Dermatology Research Associates
Los Angeles, California 90045, United States
Madera Family Medical Group
Madera, California 93637, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California 92691, United States
Palmtree Clinical Research-Clinedge-Ppds
Palm Springs, California 92262, United States
Integrated Research of Inland, Inc
Riverside, California 92506, United States
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California 90404, United States
Phdermatology
Clearwater, Florida 33756, United States
Life Clinical Trials Margate
Margate, Florida 33063, United States
Acevedo Clinical Research
Miami, Florida 33142, United States
Pediatric Center of Excellence Pce Miami Pediatric Endocrinology, Llc
Miami, Florida 33146, United States
The Childrens Skin Center Csc Miami
Miami, Florida 33155, United States
Entrust Clinical Research
Miami, Florida 33156, United States
Ciocca Dermatology Pa
Miami, Florida 33173, United States
Forcare Clinical Research
Tampa, Florida 33624, United States
Aeroallergy Research Lab of Savannah
Savannah, Georgia 31406, United States
Northwestern Memorial Hospital-Arkes Pavilion
Chicago, Illinois 60611, United States
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois 61761, United States
Northshore Medical Group Dermatology Skokie
Skokie, Illinois 60076, United States
Dermatology Specialists Research Indiana
Clarksville, Indiana 47129, United States
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana 46250, United States
Kansas City Dermatology P.A.
Lenexa, Kansas 66215, United States
Office of Michael W. Simon, Md
Nicholasville, Kentucky 40356, United States
Meridian Clinical Research
Baton Rouge, Louisiana 70808, United States
Delricht Clinical Research-Clinedge-Ppds Baton Rouge
Baton Rouge, Louisiana 70809, United States
Delricht Research-Touro Medical Center
New Orleans, Louisiana 70115, United States
Lawrence J. Green, Md. Llc
Rockville, Maryland 20850, United States
Henry Ford Medical Center-New Center One
Detroit, Michigan 48202, United States
Michigan Dermatology Institute
Waterford, Michigan 48328, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska 68144, United States
Dr Bobby Buka, Md Greenwich Village
New York, New York 10012, United States
New York University Langone Medical Center-Fink Children'S Ambulatory Care Center
New York, New York 10016, United States
Ohio Pediatric Research Association
Dayton, Ohio 45414, United States
Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc
Grants Pass, Oregon 97527, United States
Cyn3Rgy Research-Clinedge-Ppds
Gresham, Oregon 97030, United States
Velocity Clinical Research-Medford
Medford, Oregon 97504, United States
Oregon Dermatology and Research Center
Portland, Oregon 97210, United States
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033, United States
Rhode Island Hospital
Providence, Rhode Island 02903, United States
Coastal Pediatric Associates
Charleston, South Carolina 29414, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee 37130, United States
Arlington Research Center
Arlington, Texas 76011, United States
Progressive Clinical Research
San Antonio, Texas 78213, United States
Texas Dermatology Alamo Heights Office
San Antonio, Texas 78218, United States
Allergy and Asthma Care of Waco, Pa
Waco, Texas 76712, United States
Intermountain Clinical Research Icr Draper
Draper, Utah 84020, United States
Springville Dermatology
Springville, Utah 84663, United States
Jordan Valley Dermatology Center
West Jordan, Utah 84088, United States
Skindc Clinic
Arlington, Virginia 22209, United States
Pi Coor Clinical Research Llc
Burke, Virginia 22015, United States
Clinical Research Partners Llc
Richmond, Virginia 23220, United States
Dermatology Specialists of Spokane
Spokane, Washington 99202, United States
Children'S Hospital of Wisconsin
Milwaukee, Wisconsin 53226, United States
Dermatology Research Institute
Calgary, Alberta T3A 2N1, Canada
Leader Research
Hamilton, Ontario L8L 3C3, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario K2C 3N2, Canada

References and documents

Study documents

Study protocol · Feb 23, 2023
Statistical analysis plan · Jun 2, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04921969
Lead sponsor: Incyte Corporation
Responsible party: Sponsor
First posted: Jun 10, 2021
Start date: Jul 19, 2021
Primary completion: May 10, 2023
Completion: Apr 8, 2024
Results posted: Jun 10, 2024
Last update: Mar 28, 2025

Study contacts

Brett Angel, MD

study director · Incyte Corporation

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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