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)
NCT ID: NCT06122649
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
203 participants
INTERVENTIONAL
2023-11-27
2025-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Placebo-controlled Treatment Phas
Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.
apremilast
Oral tablet
Placebo
Oral tablet
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.
apremilast
Oral tablet
Interventions
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apremilast
Oral tablet
Placebo
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang First Peoples Hospital
Nanyang, Henan, China
Yichang Central Peoples Hospital
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Changshu No2 Peoples Hospital
Suzhou, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University
Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20200250
Identifier Type: -
Identifier Source: org_study_id
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