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Trial record 3 of 6 for:    INCB039110

A Study of Escalating Doses of INCB039110 Administered Orally in Patients With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01634087
First received: July 2, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This is a study of INCB039110 in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of INCB039110.


Condition Intervention Phase
Chronic Plaque Psoriasis
Drug: INCB039110
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of Oral INCB039110 in Subjects With Stable, Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Safety and tolerability of INCB039110 as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations. [ Time Frame: Approximately two months. ] [ Designated as safety issue: Yes ]
  • The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit. [ Time Frame: Approximately 28 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit. [ Time Frame: Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months). ] [ Designated as safety issue: No ]
  • Preliminary Pharmacokinetic (PK) collections. [ Time Frame: Following 15 days of therapy. ] [ Designated as safety issue: No ]
    Plasma concentrations of INCB039110 will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).


Enrollment: 50
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg QD INCB039110 Drug: INCB039110
INCB039110 administered orally
Experimental: 100 mg QD Placebo Drug: Placebo
Placebo administered orally
Experimental: 200 mg QD INCB039110 Drug: INCB039110
INCB039110 administered orally
Experimental: 200 mg QD Placebo Drug: Placebo
Placebo administered orally
Experimental: 200 mg BID INCB039110 Drug: INCB039110
INCB039110 administered orally
Experimental: 200 mg BID Placebo Drug: Placebo
Placebo administered orally
Experimental: 600 mg once a day INCB039110 Drug: INCB039110
INCB039110 administered orally
Experimental: 600 mg once a day Placebo Drug: Placebo
Placebo administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
  • Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug
  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: NCT01634087

Locations
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Los Angeles, California, United States
United States, Minnesota
Clinton Township, Minnesota, United States
Fridley, Minnesota, United States
United States, New York
Rochester, New York, United States
Canada, New Brunswick
Moncton, New Brunswick, Canada
Canada, Ontario
Windsor, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada
Quebec, Canada
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Victor Sandor, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01634087     History of Changes
Other Study ID Numbers: INCB 39110-250
Study First Received: July 2, 2012
Last Updated: November 26, 2013
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