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Completed

NCT Number: NCT01634087

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

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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moncton, New Brunswick, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itacitinib

Drug

Itacitinib administered orally

Other names: INCB039110

Placebo

Drug

Placebo administered orally

Primary outcomes

  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.

    Time frame: Approximately two months.

  2. 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

  1. 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).

  2. Preliminary Pharmacokinetic (PK) collections.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 6, 2012
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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