INCB047986 in Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.