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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820950
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ruxolitinib phosphate cream Drug: Dovonex® calcipotriene 0.005% Drug: Diprolene® AF betamethasone dipropionate 0.05% cream. Drug: Placebo cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2007
Actual Primary Completion Date : January 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%
Drug: Ruxolitinib phosphate cream
Ruxolitinib phosphate cream 0.5%
Other Name: INCB018424

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

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

Placebo Comparator: Treatment 4: Placebo
Placebo Cream
Drug: Placebo cream
Cream applied once or twice daily for 56 days

Active Comparator: Treatment 5: Dovonex® calcipotriene
Dovonex® calcipotriene 0.005% cream
Drug: Dovonex® calcipotriene 0.005%
Cream applied once or twice daily for up to 56 days.

Active Comparator: Treatment 6: Diprolene® AF betamethasone diproprionate Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
Cream applied once or twice daily for up to 56 days




Primary Outcome Measures :
  1. 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

    1. Change in target lesion scores (erythema, E; scaling, S; and thickness, T) including total score (E+S+T) and each component analyzed separately.
    2. Change in target lesion area


Secondary Outcome Measures :
  1. 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 ]


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:

  • 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.

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): NCT00820950


Locations
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United States, California
Vallejo, California, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
Rochester, New York, United States
Stony Brook, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: William Williams, MD Incyte Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00820950    
Other Study ID Numbers: INCB 18424-201
First Posted: January 12, 2009    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
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Calcipotriene
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents