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A Dose Ranging Study of the Effect of INCB018424 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 : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

October 21, 2008
October 23, 2008
January 17, 2018
October 2008
April 2009   (Final data collection date for primary outcome measure)
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
  • To evaluate the safety and tolerability of 3 different strengths of INCB018424 cream formulation compared with placebo when applied once daily to patients with plaque psoriasis. [ Time Frame: End of Study ]
  • Change in total lesion score of all psoriatic lesions [ Time Frame: End of Study ]
Complete list of historical versions of study NCT00778700 on ClinicalTrials.gov Archive Site
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
To evaluate the pharmacokinetics of 3 different dose strengths of INCB018424 cream formulation when applied once daily to patients with plaque psoriasis. [ Time Frame: End of Study ]
Not Provided
Not Provided
 
A Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
The study will be a double-blind, randomized, vehicle-controlled study with application of INCB018424 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Psoriasis
  • Drug: INCB018424 Phosphate Cream
    0.5% phosphate cream
  • Drug: Placebo Cream
    Cream with no active drug
  • Drug: INCB018424 Phosphate Cream
    1.0% phosphate cream
  • Drug: INCB018424 Phosphate Cream
    1.5% phosphate cream
  • Experimental: Treatment 1: INCB018424
    INCB018424 -- 0.5 percent phosphate cream
    Intervention: Drug: INCB018424 Phosphate Cream
  • Experimental: Treatment 2: INCB018424
    INCB018424 -- 1.0 percent phosphate cream
    Intervention: Drug: INCB018424 Phosphate Cream
  • Experimental: Treatment 3: INCB018424
    INCB018424 -- 1.5 percent phosphate cream
    Intervention: Drug: INCB018424 Phosphate Cream
  • Placebo Comparator: Treatment 4: Placebo
    Placebo cream
    Intervention: Drug: Placebo Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
April 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00778700
INCB 18424-203
No
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Monica Luchi, M.D. Incyte Corporation
Incyte Corporation
January 2018

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