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) (ESSENCE)

Amgen

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: apremilast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122649

20200250

Details and patient eligibility

About

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

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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203 participants in 2 patient groups

Placebo-controlled Treatment Phas

Experimental group

Description:

Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.

Treatment:

Drug: Placebo

Drug: apremilast

Active Treatment Phase

Experimental group

Description:

Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks.

Treatment:

Drug: apremilast