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 — DRUG
    Itacitinib administered orally
  • Placebo — DRUG
    Placebo 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)

FacilityCityStateZIPSite coordinators
-Hot SpringsArkansas--
-Los AngelesCalifornia--
-ClintonMinnesota--
-FridleyMinnesota--
-RochesterNew York--

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