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

Part of paid clinical trials in Vallejo, California.

Sponsor
Incyte Corporation
Study ID
NCT00820950
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Feb 2022
Primary completion
Jan 31, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: INCB018424 Ruxolitinib 0.5%
    INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
  • Experimental: Cohort B: INCB018424 Ruxolitinib 1.0%
    INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
  • Experimental: Cohort C: INCB018424 Ruxolitinib 1.5%
    INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
  • Experimental: Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene
    INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days
  • Experimental: Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate
    INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

Primary Outcome Measure

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline [ Time Frame: Baseline, Days 8, 15, 22, 28 and 56 ]

Locations (6)

FacilityCityStateZIPSite coordinators
-VallejoCalifornia--
-BostonMassachusetts--
-RochesterNew York--
-Stony BrookNew York--
-PortlandOregon--
-PhiladelphiaPennsylvania--

Find similar trials in Vallejo, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease

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