NCT07190391

Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis

A Multi-center, Single-arm, Open-label, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Apremilast in Patients With Moderate-to-severe Psoriasis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 425 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of Apremilast tablets in patients with psoriasis over 32 weeks, through a multicenter, single-arm, open-label, phase 4 clinical trial.

Detailed description

In this clinical trial, patients with psoriasis will be informed about study participation and written informed consent will be obtained voluntarily. Eligible participants, based on inclusion and exclusion criteria, will be assigned a registration number. Participants will receive Apremilast for 32 weeks and visit the study site at three time points: Visit 1 (screening and baseline, Week 0), Visit 2 (Week 16 ± 4), and Visit 3 (Week 32 ± 4). At each visit, demographic information, efficacy assessments, and adverse event evaluations will be conducted according to the study schedule.

Conditions

• Psoriasis

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-12-31
• Completion: 2027-10-31
• First posted: 2025-09-24
• Last updated: 2025-09-24