Plaque Psoriasis
Conditions
Brief summary
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
Interventions
DRUGItacitinib
Itacitinib administered orally
DRUGPlacebo
Placebo administered orally
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada, United States
Outcome results
None listed