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
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: INCB018424 phosphate cream
Drug: Dovonex® calcipotriene 0.005%
Drug: Diprolene® AF betamethasone dipropionate 0.05% 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, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study 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:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1: INCB018424
INCB018424 -- 0.5%
Drug: INCB018424 phosphate cream
INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
Experimental: Treatment 2: INCB018424
INCB018424 -- 1.0%
Drug: INCB018424 phosphate cream
INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
Experimental: Treatment 3: INCB018424
INCB018424 -- 1.5%
Drug: INCB018424 phosphate cream
INCB018424 phosphate cream 0.5%, 1.0% and 1.5%
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  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: NCT00820950

Locations
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
Study Director: William Williams, MD Incyte Corporation
  More Information

No publications provided by Incyte Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00820950     History of Changes
Other Study ID Numbers: INCB 18424-201
Study First Received: January 8, 2009
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 01, 2014