Phase 2
Completed N=58
A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT00820950 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline — -0.5; -0.5; -0.8; -1.0 Scores on a scale
Summary
The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline |
-0.5; -0.5; -0.8; -1.0; -0.7; -1.2 | — |
| PRIMARY Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline |
-1.3; -1.3; -1.0; -1.7; -1.7; -3.2 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events |
6; 1; 5; 4; 2 | — |
| PRIMARY Pharmacokinetics Parameter : Skin Flux of INCB018424 |
54.2; 151; 422; 363; 383 | — |
| PRIMARY Pharmacokinetics Parameter : Bioavailability of INCB018424 |
2.8; 3.0; 3.0; 2.7; 2.7 | — |
| SECONDARY Change in Target Lesion Area Compared to Baseline |
0.35; 1.53; 0.45; -3.18; -4.03; -11.45 | — |
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) of 17 to 40 kg/m2
- Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2 and these target lesions must be similar in size to each other, and separated by at least 15 cm.
Exclusion Criteria
- Subjects with lesions solely involving the palms of the hands or soles of the feet or intertriginous areas, the scalp or the face.
- Subjects with pustular psoriasis or erythroderma.
- Subjects currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication.
- Subjects receiving PUVA within 4 weeks of the first dose of study medication.
- Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral immunosuppressives within 3 months prior to the first dose of study medication.
- Subjects receiving any other biological therapy (infliximab, alefacept, abatacept, etc) within 3 months of the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT00820950). 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.