NCT01583374

Study of Apremilast to Treat Subjects With Active 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg BID and apremilast 30 mg BID. The duration of the study was approximately 5 years. The double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. At Week 16, participants who did 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 were entered in "early escape" from their current treatment in a double-blinded manner. However, such participants were permitted to continue in the study. At Week 24, participants may have entered 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 participants transitioned to receive double-blinded apremilast 30 mg BID and remained on double-blinded apremilast 30 mg BID because they continued 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 participants continued on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all participants had completed Week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg BID or 30 mg BID treatment was provided.

Conditions

• Ankylosing Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Apremilast tablet 20 mg	Apremilast 20 mg was taken orally twice a day (BID)
DRUG	Apremilast tablet 30 mg BID	Apremilast 30 mg was taken orally twice a day
DRUG	Placebo	Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

Timeline

• Start date: 2012-05-02
• Primary completion: 2014-02-24
• Completion: 2018-10-25
• First posted: 2012-04-24
• Last updated: 2020-05-12
• Results posted: 2015-03-17

Locations

103 sites across 18 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Sweden, United Kingdom