Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Escalating Doses of Itacitinib 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 : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

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

Layout table for study information
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 Itacitinib in Subjects With Stable, Chronic Plaque Psoriasis
Study Start Date : June 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 100 mg QD Itacitinib Drug: Itacitinib
Itacitinib administered orally
Other Name: INCB039110

Experimental: 100 mg QD Placebo Drug: Placebo
Placebo administered orally

Experimental: 200 mg QD Itacitinib Drug: Itacitinib
Itacitinib administered orally
Other Name: INCB039110

Experimental: 200 mg QD Placebo Drug: Placebo
Placebo administered orally

Experimental: 200 mg BID Itacitinib Drug: Itacitinib
Itacitinib administered orally
Other Name: INCB039110

Experimental: 200 mg BID Placebo Drug: Placebo
Placebo administered orally

Experimental: 600 mg once a day Itacitinib Drug: Itacitinib
Itacitinib administered orally
Other Name: INCB039110

Experimental: 600 mg once a day Placebo Drug: Placebo
Placebo administered orally




Primary Outcome Measures :
  1. Safety and tolerability of itacitinib 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 itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
Layout table for location information
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
Layout table for investigator information
Study Director: Victor Sandor, MD Incyte Corporation
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01634087    
Other Study ID Numbers: INCB 39110-250
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases