Adults 2 to 11, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8Primary· 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.
Group
Value
95% CI
VC Period: Vehicle Cream BID
10.8
4.4 – 20.9
VC Period: Ruxolitinib 0.75% Cream BID
36.6
28.4 – 45.3
VC Period: Ruxolitinib 1.5% Cream BID
56.5
47.6 – 65.1
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch Numerical Rating Scale (NRS) Score From Baseline to Week 8Secondary· 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.
Group
Value
95% CI
VC Period: Vehicle Cream BID
29.7
15.873 – 46.980
VC Period: Ruxolitinib 0.75% Cream BID
37.5
26.919 – 49.035
VC Period: Ruxolitinib 1.5% Cream BID
43.4
32.083 – 55.288
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 7 (Week 1)Secondary· 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.
Group
Value
95% CI
VC Period: Vehicle Cream BID
11.5
VC Period: Ruxolitinib 0.75% Cream BID
23.5
VC Period: Ruxolitinib 1.5% Cream BID
28.2
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Day 3Secondary· 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.
Group
Value
95% CI
VC Period: Vehicle Cream BID
4.1
VC Period: Ruxolitinib 0.75% Cream BID
14.6
VC Period: Ruxolitinib 1.5% Cream BID
12.1
VC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)Secondary· from Baseline up to Week 8
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.
Group
Value
95% CI
VC Period: Vehicle Cream BID
18
VC Period: Ruxolitinib 0.75% Cream BID
35
VC Period: Ruxolitinib 1.5% Cream BID
48
LTS Period: Number of Participants With Any TEAESecondary· From Week 8 up to Week 56
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.
Group
Value
95% CI
LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
9
LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
13
LTS Period: Ruxolitinib 0.75% Cream BID
57
LTS Period: Ruxolitinib 1.5% Cream BID
63
VC Period: Number of Participants With Any Grade 3 or Higher TEAESecondary· from Baseline up to Week 8
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 non
Group
Value
95% CI
VC Period: Vehicle Cream BID
0
VC Period: Ruxolitinib 0.75% Cream BID
0
VC Period: Ruxolitinib 1.5% Cream BID
2
LTS Period: Number of Participants With Any Grade 3 or Higher TEAESecondary· From Week 12 up to Week 56
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 non
Group
Value
95% CI
LTS Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
0
LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
0
LTS Period: Ruxolitinib 0.75% Cream BID
3
LTS Period: Ruxolitinib 1.5% Cream BID
3
VC Period: Percentage of Participants Who Achieved IGA-TS at Weeks 2 and 4Secondary· Baseline to 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.
Week 2
Group
Value
95% CI
VC Period: Vehicle Cream BID
4.6
1.0 – 12.9
VC Period: Ruxolitinib 0.75% Cream BID
24.6
17.6 – 32.8
VC Period: Ruxolitinib 1.5% Cream BID
35.1
27.0 – 43.9
Week 4
Group
Value
95% CI
VC Period: Vehicle Cream BID
12.3
5.5 – 22.8
VC Period: Ruxolitinib 0.75% Cream BID
36.6
28.4 – 45.3
VC Period: Ruxolitinib 1.5% Cream BID
48.1
39.3 – 57.0
VC Period: Percentage of Participants With a ≥4-Point Improvement in Itch NRS Score From Baseline to Week 2 and 4Secondary· Baseline to Weeks 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.
Week 2
Group
Value
95% CI
VC Period: Vehicle Cream BID
8.1
1.704 – 21.910
VC Period: Ruxolitinib 0.75% Cream BID
23.8
14.945 – 34.578
VC Period: Ruxolitinib 1.5% Cream BID
23.7
14.682 – 34.824
Week 4
Group
Value
95% CI
VC Period: Vehicle Cream BID
10.8
3.025 – 25.418
VC Period: Ruxolitinib 0.75% Cream BID
33.8
23.553 – 45.191
VC Period: Ruxolitinib 1.5% Cream BID
36.8
26.058 – 48.686
VC Period: Percentage of Participants Who Achieved Eczema Area and Severity Index 75 (EASI75) at Weeks 2, 4, and 8Secondary· Baseline to 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 = alm
Week 2
Group
Value
95% CI
VC Period: Vehicle Cream BID
6.2
1.702 – 15.013
VC Period: Ruxolitinib 0.75% Cream BID
35.8
27.728 – 44.556
VC Period: Ruxolitinib 1.5% Cream BID
43.5
34.876 – 52.447
Week 4
Group
Value
95% CI
VC Period: Vehicle Cream BID
12.3
5.466 – 22.819
VC Period: Ruxolitinib 0.75% Cream BID
53.0
44.178 – 61.658
VC Period: Ruxolitinib 1.5% Cream BID
62.6
53.718 – 70.890
Week 8
Group
Value
95% CI
VC Period: Vehicle Cream BID
15.4
7.632 – 26.478
VC Period: Ruxolitinib 0.75% Cream BID
51.5
42.708 – 60.210
VC Period: Ruxolitinib 1.5% Cream BID
67.2
58.432 – 75.123
VC Period: Time to Achieve Itch NRS Score Improvement of at Least 2 or 4 PointsSecondary· up 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 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.
Improvement of at least 2 points
Group
Value
95% CI
VC Period: Vehicle Cream BID
6.0
4.0 – 21.0
VC Period: Ruxolitinib 0.75% Cream BID
4.0
3.0 – 5.0
VC Period: Ruxolitinib 1.5% Cream BID
5.0
3.0 – 6.0
Improvement of at least 4 points
Group
Value
95% CI
VC Period: Vehicle Cream BID
23.0
13.0 – NA
VC Period: Ruxolitinib 0.75% Cream BID
11.0
9.0 – 20.0
VC Period: Ruxolitinib 1.5% Cream BID
13.0
9.0 – 17.0
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 60 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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%).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
· Phase 4
· not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (
· Phase 2
· recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
· Phase 1
· not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
· Phase 1
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 28 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04921969.