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)

Study Overview
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Brief Summary
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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

Official Title
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A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Apremilast 30 mg Twice Daily in Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: apremilast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo-controlled Treatment Phas<br>Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks. | Drug: apremilast<br>* Oral tablet<br>* Other names: Otezla®;Drug: Placebo<br>* Oral tablet<br>|
| Experimental: Active Treatment Phase<br>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. | Drug: apremilast<br>* Oral tablet<br>* Other names: Otezla®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and with ≥ 2-point Reduction From Baseline at Week 16 |  | Baseline and Week 16 | 
| Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16 |  | Baseline and Week 16 | 
| Number of Participants with Baseline Scalp Physician's Globa Assesment (ScPGA) of ≥ 2 Achieving a Clear (0) or Almost Clear (1) ScPGA and with ≥ 2-point Reduction From Baseline and at Week 16 |  | Baseline and Week 16 | 
| Percent Change of PASI From Baseline at Week 16 |  | Baseline and Week 16 | 
| Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16 |  | Baseline and Week 16 | 
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 |  | Baseline and Week 16 | 
| Number of Participants who Have a Baseline Scalp Itch NRS ≥ 4 and Achieving ≥ 4-point Reduction (Improvement) From Baseline in Scalp Itch NRS at Week 16 |  | Baseline and Week 16 | 
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. | Baseline to Week 52 | 
| Plasma Concentration of Apremilast |  | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apremilast, Dermatology