NCT06122649CompletedPhase 3
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)
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
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- First submitted
- 3 Nov 2023
- Start date
- 27 Nov 2023
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Amgen
- Diseases
- Psoriasis
- NCT number
- NCT06122649
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 203
- From 27 Nov 2023 to the primary completion date, 28 Feb 2025
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chengdu Second Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Dermatology Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Dermatology Hospital of Jiangxi Province Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanyang First Peoples Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Changshu No2 Peoples Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Peoples Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Wuxi Peoples Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Yichang Central Peoples Hospital Coordinator of this site? Confirm its status | Yichang | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.