NCT03930186

A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.

Detailed description

Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Tablets for oral administration
DRUG	Topical Therapy	Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-05-08
• Completion: 2020-09-25
• First posted: 2019-04-29
• Last updated: 2022-01-20
• Results posted: 2022-01-20

Locations

56 sites across 2 countries: Germany, Japan

Regulatory

• FDA-regulated drug study