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

Sponsor
Daewoong Pharmaceutical Co. LTD.
Study ID
NCT07190391
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 24, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
425 participants (estimated)

Arms

  • Arm: Apsola Tab.
    Apsola Tab. 10mg, Apsola Tab. 20mg, Apsola Tab. 30mg

Primary Outcome Measure

Proportion of patients who achieved PASI 75 [ Time Frame: 16 weeks ]

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