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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634087
• Other study ID #: INCB 39110-250
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Itacitinib
Itacitinib administered orally
• Placebo
Placebo administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.		Approximately 28 days.
Secondary	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).
Secondary	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.