A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
Part of paid clinical trials in Hot Springs, Arkansas.
- Sponsor
- Incyte Corporation
- Study ID
- NCT01634087
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Itacitinib — DRUGItacitinib administered orally
- Placebo — DRUGPlacebo administered orally
Study Details
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
Key Dates
- Start date
- Jun 30, 2012
- Status verified
- Mar 2019
- Primary completion
- Jan 31, 2013
- Completion
- Feb 28, 2013
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 100 mg QD Itacitinib
- Experimental: 100 mg QD Placebo
- Experimental: 200 mg QD Itacitinib
- Experimental: 200 mg QD Placebo
- Experimental: 200 mg BID Itacitinib
- Experimental: 200 mg BID Placebo
- Experimental: 600 mg once a day Itacitinib
- Experimental: 600 mg once a day Placebo
Primary Outcome Measure
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. ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Hot Springs | Arkansas | - | - |
| - | Los Angeles | California | - | - |
| - | Clinton | Minnesota | - | - |
| - | Fridley | Minnesota | - | - |
| - | Rochester | New York | - | - |
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