ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dose Ranging Study of the Effect of INCB018424 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: NCT00778700
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: INCB018424 Phosphate Cream Drug: Placebo Cream Phase 2

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 INCB018424 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
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment 1: INCB018424
INCB018424 -- 0.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5% phosphate cream
Experimental: Treatment 2: INCB018424
INCB018424 -- 1.0 percent phosphate cream
Drug: INCB018424 Phosphate Cream
1.0% phosphate cream
Experimental: Treatment 3: INCB018424
INCB018424 -- 1.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
1.5% phosphate cream
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Study Director: Monica Luchi, M.D. Incyte Corporation

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: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases