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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06550076




Registration number
NCT06550076
Ethics application status
Date submitted
8/08/2024
Date registered
12/08/2024

Titles & IDs
Public title
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Scientific title
A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
Secondary ID [1] 0 0
2024-512496-12-00
Secondary ID [2] 0 0
TAK-279-PsO-3003
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

Experimental: Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279 - Part A: Participants will receive TAK-279, oral tablet once daily (QD) for up to 52 weeks.

Part B: Participants who completed the treatment period of parent studies (TAK-279-3001 \[NCT06088043\] or TAK-279-3002 \[NCT06108544\]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.


Treatment: Drugs: TAK-279
TAK-279 oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
Timepoint [1] 0 0
From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)
Secondary outcome [1] 0 0
Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score
Timepoint [1] 0 0
Baseline up to Week 52 (Part A) and Week 156 (Part B)
Secondary outcome [2] 0 0
Part A and B: Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a >=2-point Decrease from Baseline
Timepoint [2] 0 0
Baseline up to Week 52 (Part A) and Week 156 (Part B)

Eligibility
Key inclusion criteria
Main

Part A:

* Participant is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator.
* Participant has provided written informed consent and any required privacy authorization before the initiation of any study procedures.
* Participant is aged 18 years or older at the time of consent.
* Participant has a diagnosis of chronic plaque psoriasis for >=6 months prior to the screening visit.
* Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening.
* Participant has moderate-to-severe plaque psoriasis as defined by a PASI score >=12 and a sPGA score >=3 at screening and Day 1.
* Participant has plaque psoriasis covering >=10% of his or her total BSA at screening and Day 1.
* Participant must be a candidate for phototherapy or systemic therapy.

Part B:

- Participant has completed 52 weeks of treatment (TAK-279-3001 or Part A) or 60 weeks of treatment (TAK-279-3002) in their parent study or Part A.

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Part A:

* Participant has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
* Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (e.g., inflammatory bowel disease).
* Participant has any clinically significant medical condition, evidence of an unstable clinical condition (e.g., cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results. These include but are not limited to:

1. Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
2. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the study.
3. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
4. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
5. Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
6. For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
7. Participant has any of the following cardiovascular disease history: A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (e.g., pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening. Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
8. Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the investigator.
9. Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
10. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by 1) medical history; or 2) by Columbia-Suicide Severity Rating Scale (C-SSRS) documentation at screening or by answering "yes" to Question 5 for suicidal ideation on the C-SSRS at screening; or 3) is clinically deemed to have a suicide risk by the investigator.
11. Participant has a patient health questionnaire - 8 (PHQ-8) score of 15 or above at screening.
12. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
* Participant has received any of the following biologics or biosimilar versions within the time frame indicated or 5 half-lives, whichever is longer:

1. Antibodies to interleukin (IL) -12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
2. Tumor necrosis factor inhibitor(s) (e.g., etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1.
3. Agents that modulate integrin pathways to impact lymphocyte trafficking (e.g., natalizumab) or agents that modulate B cells or T cells (e.g., alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
4. Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1.
* Participant has any previous exposure to TAK-279 (also known as NDI-034858) or other TYK2 inhibitors, including deucravacitinib, or participant participated in any study that included a TYK2 inhibitor (e.g., deucravacitinib, VTX958, GLPG3667, etc.), unless the participant has documentation of post-trial unblinding that confirms the partcipant did not receive a TYK2 inhibitor.
* Participant has a known or suspected allergy to TAK-279 or any of its components.

Part B:

* Participant has completed the parent study or Part A but was permanently discontinued from treatment.
* Participant had evidence of significant noncompliance with study visits or study drug in the parent study or Part A, as defined in the parent study protocol or in the opinion of the investigator.
* Participant has met criteria for termination from the parent study or Part A, regardless of whether or not the participant was terminated from the parent study or Part A.
* Participant has developed evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis) since enrollment in the parent study or Part A.
* Participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments.
* Participant has received a prohibited psoriasis treatment during the parent study or Part A, whether or not that treatment was documented as a concomitant medication and is expected to continue that treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
4/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/05/2026
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Center - Probity - Probity - Kogarah
Recruitment hospital [2] 0 0
The Skin Center - Probity - Benowa
Recruitment hospital [3] 0 0
Skin Health Institute Inc - Probity - PPDS - Carlton
Recruitment hospital [4] 0 0
Sinclair Dermatology-East Melbourne - East Melbourne
Recruitment hospital [5] 0 0
Alfred Health - Parkville
Recruitment hospital [6] 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
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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Seoul Teugbyeolsi
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Elblag
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Krakow
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Lublin
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Torun
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Warszawa
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Wroclaw
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Puerto Rico
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San Juan
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Spain
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Guipúzcoa
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Spain
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LAS Palmas
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Spain
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Valencia
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Spain
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Barcelona
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Taiwan
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Tainan City
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Taiwan
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Hsinchu City
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Taiwan
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Kaohsiung City
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Taiwan
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Taiwan
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Taipei
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Taiwan
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Zhong Zheng Qu
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Buckinghamshire
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Essex
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Lancashire
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London, City Of
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United Kingdom
State/province [136] 0 0
Middlesex

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/NCT06550076