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A Dose Ranging Study of the Effect 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:
NCT00778700
First received: October 21, 2008
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Plaque Psoriasis
Drug: INCB018424 Phosphate Cream
Drug: Placebo Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Sum of erythema, scaling, and thickness for all treatable lesions


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Lesion scores of 0 or 1


Enrollment: 199
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1: INCB018424
INCB018424 -- 0.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Experimental: Treatment 2: INCB018424
INCB018424 -- 1.0 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Experimental: Treatment 3: INCB018424
INCB018424 -- 1.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Placebo Comparator: Treatment 4: Placebo
Placebo cream
Drug: Placebo Cream
Cream with no active drug

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778700

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

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00778700     History of Changes
Other Study ID Numbers: INCB 18424-203
Study First Received: October 21, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014