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Trial record 5 of 20 for:    INCB039110

A Study of Escalating Doses of INCB039110 Administered Orally in 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: NCT01634087
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a study of INCB039110 in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of INCB039110.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: INCB039110 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2012
Primary Completion Date : January 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
  2. The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit. [ Time Frame: Approximately 28 days. ]

Secondary Outcome Measures :
  1. 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). ]
  2. Preliminary Pharmacokinetic (PK) collections. [ Time Frame: Following 15 days of therapy. ]
    Plasma concentrations of INCB039110 will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01634087


Locations
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Los Angeles, California, United States
United States, Minnesota
Clinton, 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

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01634087     History of Changes
Other Study ID Numbers: INCB 39110-250
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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