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)

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

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: apremilast

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Henan
    • Nanyang, Henan, China, 473002
      • Nanyang First Peoples Hospital
  • Hubei
    • Yichang, Hubei, China, 443003
      • Yichang Central Peoples Hospital
  • Hunan
    • Changsha, Hunan, China, 410011
      • The second Xiangya hospital of central south university
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Changshu No2 Peoples Hospital
    • Wuxi, Jiangsu, China, 241023
      • Wuxi Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China, 830001
      • Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Shanghai skin disease hospital
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Chengdu Second Peoples Hospital
    • Chongqing, Sichuan, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830001
      • Peoples Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Apremilast; Dermatology
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; apremilast
• Other Study ID Numbers: 20200250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes