NCT01634087
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Plaque Psoriasis
- Sponsor
- Incyte Corporation
- Enrollment
- 50
- Primary Endpoint
- The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
Investigators
Eligibility Criteria
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
Arms & Interventions
600 mg once a day Placebo
Intervention: Placebo
100 mg QD Itacitinib
Intervention: Itacitinib
100 mg QD Placebo
Intervention: Placebo
200 mg QD Itacitinib
Intervention: Itacitinib
200 mg QD Placebo
Intervention: Placebo
200 mg BID Itacitinib
Intervention: Itacitinib
200 mg BID Placebo
Intervention: Placebo
600 mg once a day Itacitinib
Intervention: Itacitinib
Outcomes
Primary Outcomes
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
Time Frame: 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.
Time Frame: Approximately two months.
Secondary Outcomes
- 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.)
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