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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Placebo; Drug: Itacitinib

• Registration Number: NCT01634087
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Disposition First Submitted: 2013-06-16
• Disposition First Submitted QC: 2013-06-16
• Disposition First Posted: 2013-06-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
600 mg once a day Placebo	Placebo	-
200 mg QD Placebo	Placebo	-
100 mg QD Placebo	Placebo	-
200 mg BID Placebo	Placebo	-
200 mg BID Itacitinib	Itacitinib	-
600 mg once a day Itacitinib	Itacitinib	-
100 mg QD Itacitinib	Itacitinib	-
200 mg QD Itacitinib	Itacitinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
Preliminary Pharmacokinetic (PK) collections.	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).