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.
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS
Patients will be assigned two different treatments based on chance (randomized) to placebo or apremilast (20 or 30 mg tablet).The duration of the study is approximately 5 years. The double blind period (when patients nor the physician knows whether placebo or apremilast is taken) is 24 weeks. At Week 16, subjects who do not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains will enter the "early escape" from their current treatment in a double-blinded manner. However, such subjects will be permitted to continue in the study. At Week 24, subjects may enter a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated subjects will be transitioned to receive double-blinded apremilast 30 mg BID; apremilast 30 mg BID will remain on double-blinded apremilast 30 mg BID because they may continue to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all subjects will continue on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all subjects have completed Week 52 or have terminated early from the study and the 52-week data base is locked, open-label apremilast 20 mg BID or 30 mg BID treatment will be provided.