INCB047986 in Rheumatoid Arthritis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to explore the safety, tolerability and efficacy of INCB047986, in subjects with moderate to severe rheumatoid arthritis.

Key facts

Study ID

NCT02151474

Run by

Incyte Corporation

People needed

3

Starts

2014-05-01

Expected to finish

2014-08-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 to 75 years, inclusive.
• Body mass index between 18 and 40 kg/m\^2, inclusive.
• Subjects must have a diagnosis of rheumatoid arthritis (RA) of at least 6 months' duration at the time of screening and must satisfy the ACR/European League Against Rheumatism (EULAR) 2010 Classification Criteria (Appendix B).
• Subjects must have active moderate to severe RA as determined by the following:
• ≥ 6 tender joints (28 joint count),
• ≥ 4 swollen joints (28 joint count), and
• CRP level ≥ 6 mg/L.
• Subjects must have a negative tuberculosis (TB) test (QuantiFERON®-TB Gold test or purified protein derivative (PPD)) at screening.

You may not qualify if…

• Current or recent history of severe and/or progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
• Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection.
• Onset of RA before the age of 16 years.
• History of known or currently suspected inflammatory disease other than RA
• Current regimen of prednisone or equivalent with an average daily dose of > 10 mg or having been treated with a stable daily dose ≤ 10 mg for < 6 weeks.
• Previous treatment with at Janus kinase (JAK) inhibitor.
• Significant impairment of bone marrow function present at screening
• Receipt of any live vaccine within 2 months before screening or anticipated need for a live vaccine within the 2 months after last dose of study drug.

Where it is running

• Study site — Orange, California, United States
• Study site — DeBary, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Frederick, Maryland, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Austin, Texas, United States
• Study site — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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