Phase 2
Completed N=307
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03011892 ↗Enrolled (actual)
307
Serious AEs
0.2%
Results posted
Apr 2021
Primary outcomePrimary: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID — -11.90; -71.57 percent change — p=< 0.0001
Summary
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID |
-11.90; -71.57 | < 0.0001 sig |
| SECONDARY Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID |
-11.90; -44.92; -52.80; -66.72 | 0.0004 sig |
| SECONDARY Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle |
-59.54; -44.92; -52.80; -66.72; -71.57 | 0.1127 |
| SECONDARY Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8 |
-4.84; -39.94; -29.96; -45.88; -49.88; -52.68 | 0.0009 sig |
| SECONDARY Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8 |
13.5; 43.1; 31.4; 57.1; 50.0; 52.0 | — |
| SECONDARY Percentage Change From Baseline in EASI Score at Week 4 |
-15.5; -59.8; -45.4; -52.2; -67.0; -71.6 | — |
| SECONDARY Time to Achieve EASI-50 |
4; 2; 4; 2; 2; 2 | — |
| SECONDARY Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8 |
1.9; 11.8; 5.9; 4.1; 13.5; 8.0 | — |
| SECONDARY Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8 |
6.0; 5.2; 6.1; 6.2; 6.2; 5.9 | — |
| SECONDARY Number of Participants With At Least One Adverse Event (AEs) and as Per Severity |
17; 17; 19; 11; 17; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
- Participants with a history of AD for at least 2 years.
- Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
Exclusion Criteria
- Participants with evidence of active acute or chronic infections.
- Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
- Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
- Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
- Participants with cytopenias at screening, defined as:
- Leukocytes 1.5 mg/dL.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
- Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
- Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
Data sourced from ClinicalTrials.gov (NCT03011892). 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. Informational only — not medical advice.