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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01634087
Collaborator
(none)
50
Enrollment
9
Locations
8
Arms
8
Duration (Months)
5.6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jun 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 100 mg QD Itacitinib

Drug: Itacitinib
Itacitinib administered orally
Other Names:
  • INCB039110

    		•
    Experimental: 100 mg QD Placebo

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

    Drug: Itacitinib
    Itacitinib administered orally
    Other Names:
  • INCB039110

    		•
    Experimental: 200 mg QD Placebo

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

    Drug: Itacitinib
    Itacitinib administered orally
    Other Names:
  • INCB039110

    		•
    Experimental: 200 mg BID Placebo

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

    Drug: Itacitinib
    Itacitinib administered orally
    Other Names:
  • INCB039110

    		•
    Experimental: 600 mg once a day Placebo

    Drug: Placebo
    Placebo administered orally

    Outcome Measures

    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. [Approximately two months.]

    2. The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit. [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. [Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).]

    2. Preliminary Pharmacokinetic (PK) collections. [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hot Springs Arkansas United States
    2 Los Angeles California United States
    3 Clinton Minnesota United States
    4 Fridley Minnesota United States
    5 Rochester New York United States
    6 Moncton New Brunswick Canada
    7 Windsor Ontario Canada
    8 Montreal Quebec Canada
    9 Quebec Canada

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Victor Sandor, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT01634087
    Other Study ID Numbers:
    • INCB 39110-250
    First Posted:
    Jul 6, 2012
    Last Update Posted:
    Mar 12, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Mar 12, 2019