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)

NCT06122649 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 20200250
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 21

Brief 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

Conditions

Plaque Psoriasis

Keywords

Apremilast; Dermatology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Placebo-controlled Treatment Phas

EXPERIMENTAL

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

Drug: apremilast; Drug: Placebo

Active Treatment Phase

EXPERIMENTAL

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

Interventions

apremilast DRUG

Oral tablet

Also known as: Otezla®

Active Treatment Phase; Placebo-controlled Treatment Phas

Placebo DRUG

Oral tablet

Placebo-controlled Treatment Phas

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (21)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Nanyang First Peoples Hospital

Nanyang, Henan, 473002, China

Location

Yichang Central Peoples Hospital

Yichang, Hubei, 443003, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Changshu No2 Peoples Hospital

Suzhou, Jiangsu, 215006, China

Location

Wuxi Peoples Hospital

Wuxi, Jiangsu, 241023, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330000, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750003, China

Location

Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University

Jinan, Shandong, 830001, China

Location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Location

Chengdu Second Peoples Hospital

Chengdu, Sichuan, 610017, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Sichuan, 400010, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Peoples Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

apremilast

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 27, 2023
• Primary Completion: February 28, 2025
• Study Completion: December 5, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CN (21)