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

Incyte Corporation50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

ItacitinibDRUG

Itacitinib administered orally

PlaceboDRUG

Placebo administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Hot Springs, Arkansas, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Clinton, Minnesota, United States

Unnamed facility

Fridley, Minnesota, United States

Outcomes

Primary Outcomes

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.

The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.

Time frame: Approximately 28 days.

Secondary Outcomes

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).

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).

Time frame: Following 15 days of therapy.

Data from ClinicalTrials.gov

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