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

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

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Itacitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg QD Itacitinib<br> | Drug: Itacitinib<br>* Itacitinib administered orally<br>* Other names: INCB039110;|
| Experimental: 100 mg QD Placebo<br> | Drug: Placebo<br>* Placebo administered orally<br>|
| Experimental: 200 mg QD Itacitinib<br> | Drug: Itacitinib<br>* Itacitinib administered orally<br>* Other names: INCB039110;|
| Experimental: 200 mg QD Placebo<br> | Drug: Placebo<br>* Placebo administered orally<br>|
| Experimental: 200 mg BID Itacitinib<br> | Drug: Itacitinib<br>* Itacitinib administered orally<br>* Other names: INCB039110;|
| Experimental: 200 mg BID Placebo<br> | Drug: Placebo<br>* Placebo administered orally<br>|
| Experimental: 600 mg once a day Itacitinib<br> | Drug: Itacitinib<br>* Itacitinib administered orally<br>* Other names: INCB039110;|
| Experimental: 600 mg once a day Placebo<br> | Drug: Placebo<br>* Placebo administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |
| --- | --- | --- |
| 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. | 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. |