Phase 2
N=199
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00778700 ↗Enrolled (actual)
199
Serious AEs
3.0%
Results posted
Feb 2022
Primary outcome: Primary: Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 — -1.07; -2.25; -2.47; -2.27 score on a scale — p=0.0041
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo Cream (Other); Ruxolitinib Phosphate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 |
-1.07; -2.25; -2.47; -2.27 | 0.0041 sig |
| SECONDARY Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness |
-0.45; -0.71; 0.84; -0.90 | — |
| SECONDARY Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema |
-0.45; -0.59; -0.72; -0.64 | — |
| SECONDARY Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling |
-0.46; -0.91; -0.87; -0.85 | — |
| SECONDARY Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness |
-17.37; -30.95; -36.56; -36.80 | — |
| SECONDARY Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema |
-15.40; -22.53; -30.74; -23.93 | — |
| SECONDARY Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling |
-17.68; -37.13; -35.38; -36.11 | — |
| SECONDARY Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 |
25.5; 55.1; 55.1; 50.0 | — |
| SECONDARY Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 |
19.1; 34.7; 46.9; 33.3 | — |
| SECONDARY Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 |
42.6; 61.2; 63.3; 50.0 | — |
| SECONDARY Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) |
-0.36; -1.63; -2.41; -1.94 | — |
| SECONDARY Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score |
-0.34; -0.73; -0.92; -0.79 | — |
| SECONDARY Percent Change From Baseline in the PGA Score |
-9.09; -22.10; -29.69; -23.33 | — |
| SECONDARY Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA |
4.3; 12.2; 32.7; 12.5 | — |
| SECONDARY Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score |
-1.49; -3.47; -3.48; -2.93 | — |
| SECONDARY Percent Change From Baseline in the PASI Score |
-18.45; -34.19; -39.97; -32.81 | — |
| SECONDARY Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point |
0.0; 0.0; 20.0; 18.8; 0.0; 11.1 | — |
| SECONDARY Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State |
9.19; 16.99; 19.97 | — |
Summary
The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.
Eligibility Criteria
Inclusion Criteria
- Plaque psoriasis involving up to 2 to 20% Body Surface Area
Exclusion Criteria
- Lesions solely involving intertriginous areas, the scalp or the face
- Systemic therapy for their psoriasis
- Pustular psoriasis or erythroderma
- Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication
- Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
- Receiving systemic triazole antifungals except fluconazole
Data sourced from ClinicalTrials.gov (NCT00778700). 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.