Phase 2
N=49
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04839380 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application) — 6.72; -3.37 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ruxolitinib cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application) |
6.72; -3.37 | — |
| SECONDARY Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 |
6.4; -2.3; -3.0; -3.3; -3.8; -4.2 | — |
| SECONDARY Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application) |
6.72; -3.78; -4.00; -4.20; -4.58; -4.78 | — |
| SECONDARY Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 |
82.6; 89.1; 89.1; 97.8; 100.0; 97.8 | — |
| SECONDARY Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 |
93.3; 95.6; 97.8; 97.8; 97.8; 97.8 | — |
| SECONDARY Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1 |
58.7; 67.4; 71.7; 91.3; 95.7; 93.5 | — |
| SECONDARY Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29 |
71.1; 82.2; 84.4; 87.0; 91.1; 95.7 | — |
| SECONDARY Time to Minimal Clinically Important Difference (MCID) for PP-NRS (≥2-grade Reduction in PP-NRS From Baseline ) |
1.6 | — |
| SECONDARY Time to MCID for mPP-NRS (≥2-grade Reduction in mPP-NRS From Baseline) |
0.817 | — |
| SECONDARY Change From Baseline in Investigator Global Assessment (IGA) at Day 8, Day 15, and Day 29 |
2.9; -1.4; -2.0; -2.2 | — |
| SECONDARY Percentage of Participants Achieving Investigator Global Assessment-Treatment Success (IGA-TS) (Score of 0 or 1 in IGA With a ≥2-grade Reduction From Baseline) at Day 8, Day 15, and Day 29 |
45.5; 71.1; 77.3 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
15 | — |
| SECONDARY Number of Participants With Any Grade 3 or Higher TEAE |
— | — |
Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
Eligibility Criteria
Inclusion Criteria
- Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
- Participant has chronic pruritus related to AD for at least 3 months .
- Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1.
- Participant has an IGA score of at least 2 on Day 1.
- Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
- Willingness to avoid pregnancy or fathering children.
- Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.
Exclusion Criteria
- Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study.
Participant had significant flares or unstable course in AD.
- Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period.
- Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
- Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
- Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
Data sourced from ClinicalTrials.gov (NCT04839380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.