A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

• Status: Recruiting
• Trial end date: 2025-12-24
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Apremilast

Criteria

Inclusion Criteria

• Chinese participants aged ≥18.

• Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0).

• Participant is a candidate for phototherapy and/or systemic therapy. Exclusion Criteria

• Psoriasis flare within 4 weeks of screening.

• Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis.

• Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.

• Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years.

• Active tuberculosis or a history of incompletely treated tuberculosis.

• History of human immunodeficiency virus (HIV) infection.

• Prior treatment with apremilast.

• Female participants of childbearing potential unwilling to use protocol specified method of contraception.

• Female participants who are breastfeeding or who plan to breastfeed.

• Female participants planning to become pregnant.