| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06550076 | A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 2,099 | — | — | Sep 4, 2024 | Aug 5, 2029 | Jun 2, 2026 | 278 | United States, Argentina +18 |
| NCT06088043 | A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment | PHASE3 | COMPLETED | 693 | — | — | Nov 6, 2023 | Oct 22, 2025 | Oct 24, 2025 | 132 | United States, Australia +8 |
| NCT06108544 | A 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 Period | PHASE3 | COMPLETED | 1,108 | — | — | Nov 6, 2023 | Nov 7, 2025 | Nov 20, 2025 | 217 | United States, Argentina +14 |
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part A (De Novo Cohort) + Part B (Open Label Extension): TAK-279 | EXPERIMENTAL | 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 \[NCT06088043\], 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-279 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Apremilast | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-279 | DRUG | TAK-279 oral tablet |
| Placebo | DRUG | Specified drug on specified days. |
| Apremilast | DRUG | Specified drug on specified days. |
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...