A Phase 2 interventional study of Itacitinib and Itacitinib Placebo in Rheumatoid Arthritis, sponsored by Incyte Corporation. Completed at 18 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 evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 106 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis 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:
Itacitinib 400 mg twice a day
Drug: Itacitinib
Itacitinib 400 mg placebo twice a day
Drug: Itacitinib Placebo
This dose group will be studied twice during the study.
Drug: Itacitinib
This dose group will be studied twice during the study.
Drug: Itacitinib Placebo
Itacitinib 100mg once a day
Drug: Itacitinib
Itacitinib 100 mg placebo once a day
Drug: Itacitinib Placebo
Itacitinib 200 mg twice a day
Drug: Itacitinib
Itacitinib 200 mg placebo twice a day
Drug: Itacitinib Placebo
Itacitinib 300 mg once a day
Drug: Itacitinib
Itacitinib 300 mg placebo once a day
Drug: Itacitinib Placebo
Itacitinib 600 mg once a day
Drug: Itacitinib
Itacitinib 600 mg placebo once a day
Drug: Itacitinib Placebo
Also known as: INCB039110
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Time frame: Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Time frame: Approximately 84 days.
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