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)

Plaque Psoriasis Clinical Trial

— ESSENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122649
• Other study ID #: 20200250
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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

External Links

•   AmgenTrials clinical trials website