Trial intelligence / Profile preview

Ruxolitinib cream in plaque psoriasis

NCT00778700Phase 2

Key facts

Status
Completed
Start
Oct 2008
Primary completion
Jun 2009
Countries
1
Sponsor
Incyte
Modality
Small Molecules
Conditions
plaque psoriasis
01

Overview

Phase 2, randomised, double-blind trial of ruxolitinib cream in plaque psoriasis (4 arms), sponsored by Incyte. Primary endpoint: Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions at Day 84. Started Oct 2008; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Vehicle Cream

    Vehicle cream applied once daily

  • Ruxolitinib 0.5%

    Ruxolitinib phosphate 0.5% cream applied once daily

  • Ruxolitinib 1.0%

    Ruxolitinib phosphate 1.0% cream applied once daily

  • Ruxolitinib 1.5%

    Ruxolitinib phosphate 1.5% cream applied once daily

03

Who it enrols

Patients with stable plaque psoriasis involving 2-20% BSA, excluding those with lesions solely on intertriginous areas/scalp/face, pustular psoriasis, or erythroderma. Patients must not be on systemic therapy or other topical agents/UVB within 2 weeks.

04

Endpoints

Primary

  • Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions

Secondary

  • Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness

  • Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema

  • Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling

  • Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness

  • Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema

  • Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling

  • Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)

  • Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score

05

Results

Primary endpoints met

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