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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06122649




Registration number
NCT06122649
Ethics application status
Date submitted
3/11/2023
Date registered
8/11/2023
Date last updated
1/11/2024

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
20200250
Universal Trial Number (UTN)
Trial acronym
ESSENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - apremilast
Treatment: Drugs - Placebo

Experimental: Placebo-controlled Treatment Phas - Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.

Experimental: 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.


Treatment: Drugs: apremilast
Oral tablet

Treatment: Drugs: Placebo
Oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Number of Participants Achieving = 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Percent Change of PASI From Baseline at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Plasma Concentration of Apremilast
Timepoint [9] 0 0
Baseline to Week 16

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Fujian
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Hebei
Country [5] 0 0
China
State/province [5] 0 0
Henan
Country [6] 0 0
China
State/province [6] 0 0
Hubei
Country [7] 0 0
China
State/province [7] 0 0
Hunan
Country [8] 0 0
China
State/province [8] 0 0
Jiangsu
Country [9] 0 0
China
State/province [9] 0 0
Jiangxi
Country [10] 0 0
China
State/province [10] 0 0
Jilin
Country [11] 0 0
China
State/province [11] 0 0
Ningxia
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Sichuan
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
China
State/province [16] 0 0
Xinjiang
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT06122649
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06122649