Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zasocitinib · 10 trials · 7 indications
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (\>) 0, less than (\<) 1.5; Mild (2) = mean \>= 1.5, \<2.5; Moderate (3) = mean \>=2.5, \<3.5; and Severe (4) = mean \>=3.5. The percentage of participants achieving an sPGA of Clear (0) or Almost Clear (1) with a \>= 2-point decrease from baseline at Week 16 will be reported.
The 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 score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to \[\<=\] 3 representing mild disease, \>= 3 to 15 representing moderate disease, and \>= 15 indicating severe disease). The PASI-75 is defined as 75% improvement from baseline in PASI score. The percentage of participants achieving \>= 75% improvement from baseline in PASI score at Week 16 will be reported.
Cmax of zasocitinib in plasma will be assessed.
Tmax of zasocitinib in plasma will be assessed.
AUC0-Last of zasocitinib in plasma will be assessed.
PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling 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 (less than or equal to \[\<=\] 3 representing mild disease, greater than or equal to \[\>=3\] to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100 percentage (%) improvement in PASI score relative to baseline PASI score will be reported.
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency after exposure to the trial intervention. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement. This is recorded as either Yes (achieved \>= 75% improvement) or No (did not achieve).
TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion.
Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.
ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion.
| Arm | Type | Description |
|---|---|---|
| Zasocitinib Dose A or Dose B | EXPERIMENTAL | Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104. |
| Re-randomized Participants - Zasocitinib Dose A or Dose B | EXPERIMENTAL | Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104. |
| Part A (Cohort 1): Zasocitinib (Dose A) | EXPERIMENTAL | Participants (Adolescent) aged 12 to less than (\<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period. |
| Part A (Cohort 2): Zasocitinib (Multiple Doses) | EXPERIMENTAL | Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period. |
| Part A (Cohort 1 and Cohort 2): Placebo | PLACEBO_COMPARATOR | Participants in Cohort 1 (Adolescent aged 12 to \<18 years) and Cohort 2 (Children aged 4 to \<12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period. |
| Part B: Zasocitinib (Multiple Doses) | EXPERIMENTAL | Participants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period. |
| Zasocitinib or Placebo | EXPERIMENTAL | Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16. |
| Deucravacitinib or Placebo | ACTIVE_COMPARATOR | Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16. |
| Zasocitinib Dose A | EXPERIMENTAL | Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52. |
| Zasocitinib Dose B | EXPERIMENTAL | Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52. |
| Placebo + Zasoctinib | EXPERIMENTAL | Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52. |
| Active Comparator Dose C | ACTIVE_COMPARATOR | Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52. |
| Zasocitinib Dose | EXPERIMENTAL | Participants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12). |
| Double-blinded: Zasocitinib (Dose A) | EXPERIMENTAL | Participants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period. |
| Double-blinded: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo from Day 1 to Week 16 during the double-blind period. |
| Open-label: Zasocitinib (Dose A) | EXPERIMENTAL | Participants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period. |
| Zasocitinib Low Dose | EXPERIMENTAL | Participants will receive Zasocitinib capsules, low dose, orally, up to Week 52. |
| Zasocitinib Medium Dose | EXPERIMENTAL | Participants will receive Zasocitinib capsules, medium dose, orally, up to Week 52. |
| Zasocitinib High Dose | EXPERIMENTAL | Participants will receive Zasocitinib capsules, high dose, orally, up to Week 52. |
| Placebo Group 1/ Zasocitinib Medium Dose | EXPERIMENTAL | Participants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52. |
| Placebo Group 2/ Zasocitinib High Dose | EXPERIMENTAL | Participants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52. |
| Cohort 1: Zasocitinib | EXPERIMENTAL | Participants with CD who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks. |
| Cohort 2: Zasocitinib | EXPERIMENTAL | Participants with UC who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks. |
| Cohort 3: Zasocitinib | EXPERIMENTAL | Participants with CD who completed Week 12 of the parent study, TAK-279-CD-2003 (NCT07403968) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks. |
| Part 1: COC (LNG and EE) + Zasocitinib | EXPERIMENTAL | - |
| Part 2: Metformin + Zasocitinib | EXPERIMENTAL | - |
| Part 3: Digoxin + Zasocitinib | EXPERIMENTAL | - |
| Part 4: Zasocitinib + Esomeprazole | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Zasocitinib | DRUG | Zasocitinib oral tablets. |
| Placebo | DRUG | Zasocitinib matching placebo. |
| Deucravacitinib | DRUG | Deucravacitinib capsules. |
| Placebo to match zasocitinib | DRUG | Zasocitinib matching placebo tablets. |
| Placebo to match deucravacitinib | DRUG | Deucravacitinib matching placebo capsules. |
| Active Comparator | DRUG | Active comparator capsule. |
| Zasocitinib (Dose A) | DRUG | Zasocitinib. |
| COC | DRUG | COC tablets (containing LNG and EE) specified doses on specified days. |
| Metformin | DRUG | Metformin tablets specified doses on specified days. |
| Digoxin | DRUG | Digoxin tablets specified doses on specified days. |
| Esomeprazole | DRUG | Esomeprazole capsules specified doses on specified days. |
Inclusion Criteria: 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \>=19 years of age. 2. The participant has completed the 52-week treatment period in one of the parent studies (TAK-...