A Phase 2 interventional study of Itacitinib and Placebo in Plaque Psoriasis, sponsored by Incyte Corporation. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Itacitinib
Drug: Placebo
Drug: Itacitinib
Drug: Placebo
Drug: Itacitinib
Drug: Placebo
Drug: Itacitinib
Drug: Placebo
Itacitinib administered orally
Also known as: INCB039110
Placebo administered orally
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.
The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
Time frame: Approximately 28 days.
Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.
Time frame: 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).
Time frame: Following 15 days of therapy.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Incyte Corporation