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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

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
29/11/2025
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
Trial website
Trial related presentations / publications
Public notes

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
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06122649