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.
Male or female patients aged ≥19 years at the time of enrollment.
Patients with moderate to severe psoriasis persisting for ≥6 months.
Patients with a PASI (Psoriasis Area and Severity Index) score between 5 and 10, requiring pharmacological treatment.
Patients who have been fully informed about the study, have understood the explanation, and have voluntarily signed the informed consent form.
Patients with a history of hypersensitivity to apremilast.
Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Pregnant or breastfeeding women.
Patients (or their spouse/partner) who do not agree to use medically acceptable and appropriate methods of contraception* during the study period.
In the ESTEEM 1 study of moderate-to-severe psoriasis, 33.1% of patients achieved PASI 75 at Week 16 with apremilast, while 28.8% did so in ESTEEM 2. Based on these results, this trial assumed a Week 16 PASI 75 response rate of \~30%. To estimate this with a 95% confidence interval and ±5% margin of error, a sample size of 340 was calculated. If the observed rate is 30%, the Clopper-Pearson method yields a lower bound of 25.2%. The study aims to present the Week 16 PASI 75 response rate with 95% confidence in a single-arm design, ensuring effect size and precision. Considering \~20% dropout, 425 subjects will be enrolled.
Case-only
Prospective
Not listed
Proportion of patients who achieved PASI 75
Proportion of patients who achieved PASI 75 at week 16
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75
Proportion of patients who achieved PASI 75 at week 32
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50
Proportion of patients who achieved PASI 50 at weeks 16
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50
Proportion of patients who achieved PASI 50 at weeks 32
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90
Proportion of patients who achieved PASI 90 at weeks 16
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