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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06088043




Registration number
NCT06088043
Ethics application status
Date submitted
12/10/2023
Date registered
18/10/2023

Titles & IDs
Public title
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
Scientific title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
Secondary ID [1] 0 0
jRCT2031230583
Secondary ID [2] 0 0
TAK-279-3001
Universal Trial Number (UTN)
Trial acronym
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 - TAK-279
Treatment: Drugs - Placebo
Treatment: Drugs - Apremilast

Experimental: TAK-279 -

Placebo comparator: Placebo -

Active comparator: Apremilast -


Treatment: Drugs: TAK-279
Specified drug on specified days.

Treatment: Drugs: Placebo
Specified drug on specified days.

Treatment: Drugs: Apremilast
Specified drug on specified days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
Timepoint [1] 0 0
Baseline, Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving >=75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI-75 Response) at Week 16 Comparing TAK-279 Against Placebo
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score >=2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants with a Baseline Psoriasis Symptoms and Signs Diary (PSSD) >=1 who Achieve Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants with Nail Involvement at Baseline Comparing TAK-279 Against Placebo
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Timepoint [8] 0 0
Baseline and Week 16
Secondary outcome [9] 0 0
Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Timepoint [9] 0 0
Baseline and Week 16
Secondary outcome [10] 0 0
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo
Timepoint [10] 0 0
Baseline and Week 16
Secondary outcome [11] 0 0
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo
Timepoint [12] 0 0
Baseline and Week 16
Secondary outcome [13] 0 0
Change from Baseline in the EuroQoL 5-Dimension 5-level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo
Timepoint [13] 0 0
Baseline and Week 16
Secondary outcome [14] 0 0
Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo
Timepoint [14] 0 0
Week 16
Secondary outcome [15] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [15] 0 0
Baseline and Week 16
Secondary outcome [16] 0 0
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [16] 0 0
Week 16
Secondary outcome [17] 0 0
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [17] 0 0
Week 16
Secondary outcome [18] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [18] 0 0
Baseline and Week 24
Secondary outcome [19] 0 0
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [19] 0 0
Week 24
Secondary outcome [20] 0 0
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [20] 0 0
Week 24
Secondary outcome [21] 0 0
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [21] 0 0
Baseline and Week 16
Secondary outcome [22] 0 0
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [23] 0 0
Week 16
Secondary outcome [24] 0 0
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [24] 0 0
Week 24
Secondary outcome [25] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [25] 0 0
Week 16
Secondary outcome [26] 0 0
Percentage of Participants with a Baseline DLQI Score >=2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [26] 0 0
Week 16
Secondary outcome [27] 0 0
Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast
Timepoint [27] 0 0
Week 16
Secondary outcome [28] 0 0
Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [28] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [29] 0 0
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [29] 0 0
Baseline and Week 24
Secondary outcome [30] 0 0
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [30] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [31] 0 0
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [31] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [32] 0 0
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [32] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [33] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [33] 0 0
Week 24
Secondary outcome [34] 0 0
Percentage of Participants with a Baseline DLQI Score >=2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [34] 0 0
Week 24
Secondary outcome [35] 0 0
Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast
Timepoint [35] 0 0
Week 24
Secondary outcome [36] 0 0
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [36] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [37] 0 0
Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [37] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [38] 0 0
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [38] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [39] 0 0
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [39] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [40] 0 0
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Timepoint [40] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [41] 0 0
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast
Timepoint [41] 0 0
Baseline, Weeks 24, 40 and 52
Secondary outcome [42] 0 0
Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast
Timepoint [42] 0 0
Weeks 24, 40 and 52
Secondary outcome [43] 0 0
Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast
Timepoint [43] 0 0
Weeks 24, 40 and 52
Secondary outcome [44] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
Timepoint [44] 0 0
Up to Week 56
Secondary outcome [45] 0 0
Number of Participants with Clinically Significant Vital Signs
Timepoint [45] 0 0
Up to Week 56
Secondary outcome [46] 0 0
Number of Participants with Clinically Significant Laboratory Values
Timepoint [46] 0 0
Up to Week 56
Secondary outcome [47] 0 0
Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings
Timepoint [47] 0 0
Up to Week 56

Eligibility
Key inclusion criteria
1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2026
Actual
Sample size
Target
Accrual to date
Final
693
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Center - Probity - PPDS - Kogarah
Recruitment hospital [2] 0 0
The Skin Center - Probity - PPDS - Benowa
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Brisbane
Recruitment hospital [4] 0 0
Skin Health Institute Inc - Probity - PPDS - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology-East Melbourne - East Melbourne
Recruitment hospital [6] 0 0
Alfred Health - Parkville
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3004 - Parkville
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Chongqing
Country [23] 0 0
China
State/province [23] 0 0
Fujian
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Hebei
Country [26] 0 0
China
State/province [26] 0 0
Hubei
Country [27] 0 0
China
State/province [27] 0 0
Liaoning
Country [28] 0 0
China
State/province [28] 0 0
Ningxia
Country [29] 0 0
China
State/province [29] 0 0
Shaanxi
Country [30] 0 0
China
State/province [30] 0 0
Shandong
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
Germany
State/province [33] 0 0
Brandenburg
Country [34] 0 0
Germany
State/province [34] 0 0
Niedersachsen
Country [35] 0 0
Germany
State/province [35] 0 0
Nordrhein-Westfalen
Country [36] 0 0
Germany
State/province [36] 0 0
Schleswig-Holstein
Country [37] 0 0
Italy
State/province [37] 0 0
Abruzzo
Country [38] 0 0
Italy
State/province [38] 0 0
Campania
Country [39] 0 0
Italy
State/province [39] 0 0
Liguria
Country [40] 0 0
Italy
State/province [40] 0 0
Lombardia
Country [41] 0 0
Italy
State/province [41] 0 0
Sicilia
Country [42] 0 0
Italy
State/province [42] 0 0
Toscana
Country [43] 0 0
Japan
State/province [43] 0 0
Aiti
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaidô
Country [45] 0 0
Japan
State/province [45] 0 0
Hukuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Kagosima
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Japan
State/province [49] 0 0
Totigi
Country [50] 0 0
Japan
State/province [50] 0 0
Kumamoto
Country [51] 0 0
Japan
State/province [51] 0 0
Ôsaka
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Busan Gwangyeogsi
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Daejeon Gwang'yeogsi
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Georgia
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Gwangju Gwang'yeogsi
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Gyeonggido
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul Teugbyeolsi
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Wonju
Country [60] 0 0
Poland
State/province [60] 0 0
Dolnoslaskie
Country [61] 0 0
Poland
State/province [61] 0 0
Lubelskie
Country [62] 0 0
Poland
State/province [62] 0 0
Lódzkie
Country [63] 0 0
Poland
State/province [63] 0 0
Mazowieckie
Country [64] 0 0
Poland
State/province [64] 0 0
Podlaskie
Country [65] 0 0
Poland
State/province [65] 0 0
Pomorskie
Country [66] 0 0
Poland
State/province [66] 0 0
Slaskie
Country [67] 0 0
Poland
State/province [67] 0 0
Wielkopolskie
Country [68] 0 0
Poland
State/province [68] 0 0
Zachodniopomorskie
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Krakow
Country [71] 0 0
Poland
State/province [71] 0 0
Lodz
Country [72] 0 0
Taiwan
State/province [72] 0 0
Hsinchu
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung City
Country [74] 0 0
Taiwan
State/province [74] 0 0
New Taipei City
Country [75] 0 0
Taiwan
State/province [75] 0 0
Tainan
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei City
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taoyuan City
Country [79] 0 0
Taiwan
State/province [79] 0 0
Zhong Zheng Qu

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
medinfoUS@takeda.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?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


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/NCT06088043