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

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

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Itacitinib

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
  • Ontario
    • Windsor, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
  • California
    • Los Angeles, California, United States
  • Minnesota
    • Clinton, Minnesota, United States
    • Fridley, Minnesota, United States
  • New York
    • Rochester, New York, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.	Approximately 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Following 15 days of therapy.
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).

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Victor Sandor, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: INCB 39110-250