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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06122649
Other study ID # 20200250
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 27, 2023
Est. completion date December 24, 2025

Study information

Verified date May 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 24, 2025
Est. primary completion date March 17, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
apremilast
Oral tablet
Placebo
Oral tablet

Locations

Country Name City State
China Peking University First Hospital Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Chengdu Second Peoples Hospital Chengdu Sichuan
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Dermatology Hospital of Southern Medical University Guangzhou Guangdong
China Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine Hangzhou Zhejiang
China Shandong Province Hospital of Dermatology Jinan Shandong
China Dermatology Hospital of Jiangxi Province Nanchang Jiangxi
China Nanyang First Peoples Hospital Nanyang Henan
China Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China Shanghai Skin Disease Hospital Shanghai
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China Tianjin Medical University General Hospital Tianjin Tianjin
China Xinjiang Uygur Municipal Peoples Hospital Urumqi Xinjiang
China Wuxi Peoples Hospital Wuxi Jiangsu
China Yichang Central Peoples Hospital Yichang Hubei
China General Hospital of Ningxia Medical University Yinchuan Ningxia

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Percent Change of PASI From Baseline at Week 16 Baseline and Week 16
Secondary Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16 Baseline and Week 16
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 Baseline and Week 16
Secondary 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
Secondary 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
Secondary Plasma Concentration of Apremilast Baseline to Week 16
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