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TAK-279

Phase 3

Plaque Psoriasis | Small molecule | Immunology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment3,900
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06550076A Study of TAK-279 in Participants With Moderate-to-Severe Plaque PsoriasisPHASE3 ACTIVE NOT_RECRUITING 2,099Sep 4, 2024Aug 5, 2029Jun 2, 2026278 United States, Argentina +18
NCT06088043A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of TreatmentPHASE3 COMPLETED 693Nov 6, 2023Oct 22, 2025Oct 24, 2025132 United States, Australia +8
NCT06108544A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment PeriodPHASE3 COMPLETED 1,108Nov 6, 2023Nov 7, 2025Nov 20, 2025217 United States, Argentina +14
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Study Endpoints
Primary Endpoints
Part A and Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
From start of the drug administration up to Week 56 (Part A) and Week 160 (Part B)

A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.

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
Baseline, Week 16

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.

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
Baseline, Week 16

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.

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
Baseline, Week 16

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.

Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
Baseline, Week 16

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.

Secondary Endpoints
Part A and B: Number of Participants Achieving 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI-75) Score
Baseline up to Week 52 (Part A) and Week 156 (Part B)
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
Baseline up to Week 52 (Part A) and Week 156 (Part B)
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo
Baseline, Week 16
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279EXPERIMENTALPart 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 \[NCT06088043\], TAK-279-3002 \[NCT06108544\], or TAK-279-PsO-3004 \[NCT06973291\]) or who completed Part A will receive TAK-279, oral tablet QD for up to 156 weeks.
TAK-279EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ApremilastACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TAK-279DRUGTAK-279 oral tablet
PlaceboDRUGSpecified drug on specified days.
ApremilastDRUGSpecified drug on specified days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites278

Main Inclusion Criteria: 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 auth...

Countries:United StatesArgentinaAustraliaBulgariaCanadaChinaCzechiaFranceGermanyHungaryIsraelItalyJapanLatviaPolandPuerto RicoSouth KoreaSpainTaiwanUnited KingdomGreece
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT06550076Enrollment: 1950 → 2099
MEDIUMJun 2, 2026NCT06550076Enrollment: 1950 → 2099
MEDIUMJun 2, 2026NCT06550076Enrollment: 1950 → 2099
LOWMay 26, 2026NCT06550076primaryCompletionDate: changed
LOWMay 24, 2026NCT06550076studyFirstPostDate: changed