NCT00521339

Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

A Phase 2, Open-label Multi-center Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Apremilast in Subjects With Recalcitrant Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis.

Detailed description

This is a phase 2, multicenter, open-label, study to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and efficacy of Apremilast in participants with recalcitrant plaque-type psoriasis. Approximately 31 participants were enrolled and received 20 mg apremilast orally BID and, in participants who are non-responders after 84 days of apremilast, 30 mg Apremilast over the course of the two study treatment phases. The study consisted of four phases: Screening Phase - up to 35 days, Treatment Phase of 84 days, Extension Phase of 84 days and a Observational Follow-up Phase of 28 days. During the Treatment Phase, participants received two 20 mg Apremilast capsules each day. Following the Treatment Phase, participants had the option to continue on treatment during the Extension Phase. During the Extension Phase, participants either continued to take two 20 mg or dose escalated to two 30 mg of Apremilast each day. Participants who were considered responders (achieved a Psoriasis Area and Severity Index (PASI-75) at the beginning of the Extension Phase continued on 20 mg twice per day (BID) while the remaining participants received 30 mg capsules BID. The Extension Phase was introduced after some participants had already completed the study; therefore, there were several participants who never had the opportunity to continue into the Extension Phase. All participants were asked to participate in a 4-week post-treatment observational follow-up phase either upon completion of the study or upon discontinuation of study drug for those participants who terminated the study early.

Conditions

• Psoriasis-Type Psoriasis
• Plaque-Type Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2007-08-27
• Last updated: 2020-05-07
• Results posted: 2014-10-21

Locations

4 sites across 1 country: United States