Back to resultsA Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Itacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
100 mg QD Itacitinib
100 mg QD Placebo
200 mg QD Itacitinib
200 mg QD Placebo
200 mg BID Itacitinib
200 mg BID Placebo
600 mg once a day Itacitinib
600 mg once a day Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
Secondary Outcome Measures
Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.
Preliminary Pharmacokinetic (PK) collections.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01634087
Brief Title
A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 mg QD Itacitinib
Arm Type
Experimental
Arm Title
100 mg QD Placebo
Arm Type
Experimental
Arm Title
200 mg QD Itacitinib
Arm Type
Experimental
Arm Title
200 mg QD Placebo
Arm Type
Experimental
Arm Title
200 mg BID Itacitinib
Arm Type
Experimental
Arm Title
200 mg BID Placebo
Arm Type
Experimental
Arm Title
600 mg once a day Itacitinib
Arm Type
Experimental
Arm Title
600 mg once a day Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Itacitinib
Other Intervention Name(s)
INCB039110
Intervention Description
Itacitinib administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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).
Title
Preliminary Pharmacokinetic (PK) collections.
Description
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Time Frame
Following 15 days of therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Sandor, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Clinton
State/Province
Minnesota
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Moncton
State/Province
New Brunswick
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
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