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A Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00820950
First received: January 8, 2009
Last updated: March 13, 2012
Last verified: March 2012
History of Changes

January 8, 2009
March 13, 2012
May 2007
January 2009   (final data collection date for primary outcome measure)
Efficacy of INCB018424, 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) ] [ Designated as safety issue: No ]

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
The safety, tolerability (assessed by local irritation, adverse experiences, vital signs, ECGs, and clinical labs) and pharmacokinetics (plasma concentrations) of INCB018424 cream formulations when applied once or twice daily to patients. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00820950 on ClinicalTrials.gov Archive Site
Characterize the safety of INCB018424 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 ] [ Designated as safety issue: Yes ]
Efficacy endpoints will include: Change in target lesion scores including total score and each component analyzed separately. Change in target lesion area [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

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 INCB018424 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 INCB018424 with two FDA approved products in patients with active but stable plaque psoriasis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: INCB018424 phosphate cream
    INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
  • 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
  • Experimental: Treatment 1: INCB018424
    INCB018424 -- 0.5%
    Intervention: Drug: INCB018424 phosphate cream
  • Experimental: Treatment 2: INCB018424
    INCB018424 -- 1.0%
    Intervention: Drug: INCB018424 phosphate cream
  • Experimental: Treatment 3: INCB018424
    INCB018424 -- 1.5%
    Intervention: Drug: INCB018424 phosphate cream
  • Placebo Comparator: Treatment 4: Placebo
    Placebo Cream
    Intervention: Drug: Placebo cream
  • Active Comparator: Treatment 5: Dovonex® calcipotriene
    Dovonex® calcipotriene 0.005% cream
    Intervention: Drug: Dovonex® calcipotriene 0.005%
  • Active Comparator: Treatment 6: Diprolene® AF betamethasone diproprionate
    Intervention: Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
Punwani N, Scherle P, Flores R, Shi J, Liang J, Yeleswaram S, Levy R, Williams W, Gottlieb A. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012 Oct;67(4):658-64. doi: 10.1016/j.jaad.2011.12.018. Epub 2012 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
April 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00820950
INCB 18424-201
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: William Williams, MD Incyte Corporation
Incyte Corporation
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP