Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-279 · 12 trials · 8 indications
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.
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 mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).
Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
AUC0-t of TAK-279 in plasma will be assessed.
AUC0-inf of TAK-279 in plasma will be assessed.
Cmax of TAK-279 in plasma will be assessed.
AUCtau of TAK-279 in plasma will be assessed.
Cmax,ss of TAK-279 in plasma will be assessed.
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
| 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 for Generalized Pustular Psoriasis | EXPERIMENTAL | Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52. |
| TAK-279 for Erythrodermic Psoriasis | EXPERIMENTAL | Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52. |
| TAK-279 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Apremilast | ACTIVE_COMPARATOR | - |
| TAK-279 Dose 1 | EXPERIMENTAL | TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response. |
| TAK-279 Dose 2 | EXPERIMENTAL | TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response. |
| TAK-279 Dose 3 | EXPERIMENTAL | Participants will be randomized to receive TAK-279 Dose 3 capsules orally. |
| Cohort 1: TAK-279 30 mg | EXPERIMENTAL | Participants will receive a single dose of TAK-279 30 milligram (mg) oral tablet on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
| Cohort 2: TAK-279 60 mg | EXPERIMENTAL | Participants will receive a dose of TAK-279 60 mg (2\*30mg) oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
| Cohort 1 and 2: Placebo 30 mg or 60 mg | PLACEBO_COMPARATOR | Participants will receive TAK-279 30 mg or 60 mg (2\*30mg) matching placebo oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
| Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo | EXPERIMENTAL | Participants will receive TAK-279 Dose 1 and matching placebo, capsules, once daily (QD) on Days 1 to 7 with moxifloxacin matching placebo, capsule, once on Days 1 and 8. |
| Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo | EXPERIMENTAL | Participants will receive TAK-279 Dose 2, capsules, QD on Days 1 to 7 with moxifloxacin matching placebo, capsule once on Days 1 and 8. |
| Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo | EXPERIMENTAL | Participants will receive moxifloxacin Dose 3, over-encapsulated tablet on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin placebo, capsule, once on Day 8. |
| Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin | EXPERIMENTAL | Participants will receive moxifloxacin matching placebo, capsule on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin Dose 3, over-encapsulated tablet, once on Day 8. |
| Treatment A: Midazolam 2 mg | EXPERIMENTAL | Midazolam 2 mg (1 milliliter \[mL\] of 2 milligram per milliliter \[mg/mL\]), syrup, orally, on Day 1 of Period 1. |
| Treatment B: Repaglinide 0.5 mg | EXPERIMENTAL | Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 2 of Period 1. |
| Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg | EXPERIMENTAL | TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Midazolam 2 mg (1 mL of 2 mg/mL), syrup, orally, on Day 14 of Period 2. |
| Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg | EXPERIMENTAL | TAK-279 Dose 1, capsules, orally, on Days 1 through 15 of Period 2 followed by Repaglinide 0.5 mg (1\*0.5 mg), tablets, orally, on Day 15 of Period 2. |
| Cohort 1, Severe RI: TAK-279 50 mg | EXPERIMENTAL | Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. |
| Cohort 2, Normal Renal Function: TAK-279 50 mg | EXPERIMENTAL | Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. |
| Cohort 3, Moderate RI: TAK-279 50 mg | EXPERIMENTAL | Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study. |
| Cohort 1, Moderate HI: TAK-279 50 mg | EXPERIMENTAL | Participants with moderate HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. |
| Cohort 2, Normal Hepatic Function: TAK-279 50 mg | EXPERIMENTAL | Participants with normal hepatic function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Based on an evaluation of the results from Part A, additional participants with normal hepatic function may be enrolled in Part B of the study. |
| Cohort 3, Mild/Severe HI: TAK-279 50 mg | EXPERIMENTAL | Participants with mild/severe HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study based on an evaluation of the results from Part A. |
| Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg | EXPERIMENTAL | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study. |
| Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg | EXPERIMENTAL | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study. |
| Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg | EXPERIMENTAL | Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study. |
| Name | Type | Description |
|---|---|---|
| TAK-279 | DRUG | TAK-279 oral tablet |
| Placebo | DRUG | Specified drug on specified days. |
| Apremilast | DRUG | Specified drug on specified days. |
| TAK-279 Placebo | DRUG | TAK-279 matching placebo capsule. |
| Moxifloxacin | DRUG | Moxifloxacin over-encapsulated tablet. |
| Moxifloxacin Placebo | DRUG | Moxifloxacin matching placebo capsule. |
| Midazolam | DRUG | Midazolam syrup. |
| Repaglinide | DRUG | Repaglinide tablets. |
| Erythromycin | DRUG | Erythromycin tablets |
| Phenytoin | DRUG | Phenytoin capsules |
| Efavirenz | DRUG | Efavirenz tablets |
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...
TAK-279 is an investigational small molecule being studied for several conditions, including plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, Crohn's disease, ulcerative colitis, hepatic impairment, renal impairment, and in healthy volunteers. It is in clinical development and has not been approved by regulatory authorities.
TAK-279 targets TYK2, a tyrosine kinase enzyme involved in inflammatory signaling pathways. By inhibiting TYK2, the drug aims to reduce inflammation associated with autoimmune and inflammatory conditions such as psoriasis and Crohn's disease.
TAK-279 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
TAK-279 is in Phase 2 and Phase 3 clinical trials. Phase 2 studies are evaluating the drug in Crohn's disease, while Phase 3 studies are assessing it in generalized pustular psoriasis, erythrodermic psoriasis, and plaque psoriasis. It remains investigational and is not yet approved.
TAK-279 has four clinical trials. NCT06233461 is a Phase 2 study in Crohn's disease, currently recruiting. NCT06323356 is a Phase 3 study in generalized pustular psoriasis and erythrodermic psoriasis, completed. NCT06550076 is a Phase 3 study in plaque psoriasis, active but not recruiting. NCT05992155 is a Phase 1 study in renal impairment and healthy volunteers, completed.
TAK-279 is the sole name provided for this investigational drug. No alternative names have been associated with it in the available clinical trial information.