Clinical trial NCT06122649: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Apremilast
Dermatology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 16
measure: Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Baseline and Week 16
measure: Percent Change of PASI From Baseline at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Baseline and Week 16
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 52
measure: Plasma Concentration of Apremilast
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanyang
country: China
facility: Nanyang First Peoples Hospital
state: Henan
city: Yichang
country: China
facility: Yichang Central Peoples Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: Changshu No2 Peoples Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Provincial Hospital For Skin Diseases,Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Second Peoples Hospital
state: Sichuan
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Urumqi
country: China
facility: Peoples Hospital of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: