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

NCT07190391 | Not Yet Recruiting

• 1 other identifier: DWAPS_P401
• Study Type: observational
• Target: 425
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieved PASI 75

  Proportion of patients who achieved PASI 75 at week 16

  16 weeks

Secondary Outcomes (21)

• [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75

  32 weeks

• [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50

  16 weeks

• [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50

  32 weeks

• [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90

  16 weeks

• [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90

  32 weeks

Study Arms (1)

Apsola Tab.

Apsola Tab. 10mg, Apsola Tab. 20mg, Apsola Tab. 30mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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 who are considered cooperative and able to participate until the end of the study.

You may not qualify if:

• 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.
• \* Medically acceptable and appropriate methods of contraception include: hormonal contraception (implants, injectables, oral contraceptives, etc.), intrauterine devices (copper IUD, hormone-releasing intrauterine system), salpingectomy, tubal ligation, hysterectomy, vasectomy, dual barrier methods (male condom and female condom, cervical cap, diaphragm, contraceptive sponge used in combination), or single barrier method combined with spermicide.
• Patients receiving strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort).
• Patients with severe renal impairment requiring hemodialysis or peritoneal dialysis.
• Patients who have previously received Apremilast (ApsoLla®) prior to enrollment, or those currently participating in another clinical trial involving an investigational medicinal product or medical device.
• (However, patients enrolled in non-interventional studies or who have completed participation in another clinical trial are eligible.)
• Patients with a history of psychiatric disorders (e.g., substance abuse, depression).
• Patients who, in the opinion of the investigator, are otherwise considered unsuitable for participation in this study.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09