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A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00778700
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The study will be a double-blind, randomized, vehicle-controlled study with application of ruxolitinib phosphate cream or vehicle in patients with stable plaque psoriasis. Application will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50 subjects each.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ruxolitinib Phosphate Cream Drug: Placebo Cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Study Start Date : October 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Treatment 1: Ruxolitinib
Ruxolitinib -- 0.5 percent phosphate cream
Drug: Ruxolitinib Phosphate Cream
0.5% phosphate cream
Other Name: INCB018424

Experimental: Treatment 2: Ruxolitinib
Ruxolitinib -- 1.0 percent phosphate cream
Drug: Ruxolitinib Phosphate Cream
1.0% phosphate cream
Other Name: INCB018424

Experimental: Treatment 3: Ruxolitinib
Ruxolitinib -- 1.5 percent phosphate cream
Drug: Ruxolitinib Phosphate Cream
1.5% phosphate cream
Other Name: INCB018424

Placebo Comparator: Treatment 4: Placebo
Placebo cream
Drug: Placebo Cream
Cream with no active drug




Primary Outcome Measures :
  1. Absolute change from Baseline to Day 84 in total lesion score for all treatable psoriatic lesions. [ Time Frame: Baseline and Day 84 (or early study termination visit) ]
    Sum of erythema, scaling, and thickness for all treatable lesions


Secondary Outcome Measures :
  1. Percentage of subjects achieving none (score=0) and mild (score=1) in each of the individual lesion scores at Day 84 [ Time Frame: Baseline and Day 84 ]
    Lesion scores of 0 or 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plaque psoriasis involving up to 2 to 20% Body Surface Area

Exclusion Criteria:

  • Lesions solely involving intertriginious areas, the scalp or the face
  • Systemic therapy for their psoriasis
  • Pustular psoriasis or erythroderma
  • Currently on other topical agents or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778700


  Show 28 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Monica Luchi, M.D. Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00778700     History of Changes
Other Study ID Numbers: INCB 18424-203
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases