A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

Overview

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.

Full Title of Study: “A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Ruxolitinib phosphate cream
    • Ruxolitinib phosphate cream 0.5%
  • Drug: Dovonex® calcipotriene 0.005%
    • Cream applied once or twice daily for up to 56 days.
  • Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
    • Cream applied once or twice daily for up to 56 days
  • Drug: Placebo cream
    • Cream applied once or twice daily for 56 days
  • Drug: Ruxolitinib phosphate cream
    • Ruxolitinib phosphate cream 1.0%
  • Drug: Ruxolitinib phosphate cream
    • Ruxolitinib phosphate cream 1.5%

Arms, Groups and Cohorts

  • Experimental: Treatment 1: Ruxolitinib
    • Ruxolitinib — 0.5%
  • Experimental: Treatment 2: Ruxolitinib
    • Ruxolitinib — 1.0%
  • Experimental: Treatment 3: Ruxolitinib
    • Ruxolitinib — 1.5%
  • Placebo Comparator: Treatment 4: Placebo
    • Placebo Cream
  • Active Comparator: Treatment 5: Dovonex® calcipotriene
    • Dovonex® calcipotriene 0.005% cream
  • Active Comparator: Treatment 6: Diprolene® AF betamethasone diproprionate

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of ruxolitinib, 0.5%, 1.0%, and 1.5% cream formulation applied once or twice daily compared with vehicle, Dovonex® calcipotriene 0.005% cream or Diprolene® AF betamethasone dipropionate 0.05% cream.
    • Time Frame: Baseline, Week 1, 2, 3, 4 and 8 (or early study termination visit)
    • Efficacy endpoints will include: Efficacy Endpoint Change in target lesion scores (erythema, E; scaling, S; and thickness, T) including total score (E+S+T) and each component analyzed separately. Change in target lesion area

Secondary Measures

  • Characterize the safety of ruxolitinib 0.5%, 1.0% and 1.5% cream formulations when applied once or twice daily by monitoring the frequency, duration and severity of adverse and serious adverse events
    • Time Frame: Baseline, Week 1, 2, 3, 4 and 8 (or early study termination visit). In addition, safety will also be assessed through the spontaneous reporting of serious adverse events

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Incyte Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William Williams, MD, Study Director, Incyte Corporation

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