Phase 2
N=186
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
Hand Eczema
Bottom Line
View on ClinicalTrials.gov: NCT05906628 ↗Enrolled (actual)
186
Serious AEs
2.3%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16 — 53.2; 10.9 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib cream (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16 |
53.2; 10.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 |
46.7; 17.6; 52.2; 23.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) |
12.9; 6.0; 28.0; 9.5 | 0.1789 |
| SECONDARY Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit |
22.5; 1.2; 37.8; 4.8; 44.3; 3.8 | <0.0001 sig |
| SECONDARY Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit |
6.68; 6.63; -3.03; -1.34; -3.88; -2.02 | — |
| SECONDARY Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score |
15.0; 29.0 | 0.0025 sig |
| SECONDARY Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit |
6.14; 6.06; -2.86; -1.27; -3.82; -1.83 | — |
| SECONDARY Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 |
59.0; 34.1; 76.7; 47.5; 74.4; 52.0 | — |
| SECONDARY Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score |
5.0; 8.0 | 0.1319 |
| SECONDARY Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 |
-54.93; -16.68; -69.58; -26.00; -77.25; -33.81 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit |
1.85; 3.21; 1.74; 3.09; 1.64; 3.04 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 |
13.17; 11.84; -7.95; -3.62; -8.68; -4.78 | — |
| SECONDARY Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 |
70; 73; 14; 8; 5; 6 | — |
| SECONDARY Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 |
74.21; 73.93; 8.85; 4.05; 10.73; 5.38 | — |
| SECONDARY Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up |
75.19; 66.52; -43.16; -21.98; -50.22; -25.10 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up |
5.68; 2.32; -4.90; -0.90; -3.15; 0.82 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period |
36; 29 | — |
| SECONDARY Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period |
2; 1 | — |
| SECONDARY Number of Participants With Any TEAE in the OLE Period |
10; 25 | — |
| SECONDARY Number of Participants With Any ≥Grade 3 TEAE in the OLE Period |
1; 1 | — |
| SECONDARY Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period |
0; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
- Screening and baseline IGA-CHE 3 or 4.
- Baseline CHE-related Itch NRS ≥ 4.
- Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
- Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
Exclusion Criteria
- Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
- Any serious illness or medical, physical, or psychiatric condition(s).
- Laboratory values outside of the protocol-defined criteria.
- Use of protocol-defined treatments within the indicated washout period before baseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05906628). 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.