Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

• Status: Completed
• Trial end date: 2018-10-25
• Target enrollment: 0
• Participant gender: All

Summary

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Celgene Corporation
• Treatments: Apremilast; Thalidomide

Criteria

Inclusion Criteria:

• Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4

• Total back pain is ≥ 4

• On stable dose of AS medication (or lack of medication) prior to randomization and through week 24

Exclusion Criteria:

• Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS