A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis

• Status: Terminated
• Trial end date: 2009-09-29
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.

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

Details

• Lead Sponsor: Array BioPharma; Pfizer

Criteria

Key Inclusion Criteria:

• Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).

• Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.

• If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.

• Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).

• Additional criteria exist.

Key Exclusion Criteria:

• Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.

• Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.

• Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.

• Trauma or other major surgeries within 8 weeks prior to first dose of study drug.

• Specific abnormal laboratory values or electrocardiogram abnormalities.

• Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.

• Additional criteria exist.