A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis

Conditions

Moderate to Severe Plaque Psoriasis

Brief summary

100% improvement from baseline in Psoriasis Area and Severity Index (PASI-100) response: Proportion of participants achieving PASI-100 at Week 16.

Detailed description

1. PASI-90 response: Proportion of participants achieving PASI-90 at Week 16., 2. Absolute PASI ≤2 response: Proportion of participants achieving PASI ≤2 at Week 16., 3. Enhanced static Physician’s Global Assessment (sPGA) response: Proportion of participants achieving an sPGA of clear (0) at Week 16., 4. PASI-100, PASI-90, sPGA 0, and absolute PASI ≤2 response at Weeks 4, 8, and 12., 5. PASI-75 and sPGA 0/1 at Weeks 4, 8, 12, and 16., 6. Change from baseline and percent change from baseline in PASI score at Weeks 4, 8, 12, and 16., 7. Incidence of treatment-emergent adverse events (TEAEs), 8. Incidence of serious adverse events (SAEs)., 9. Incidence of adverse events of special interest (AESIs)., 10. Changes in vital signs, clinical laboratory parameters, and electrocardiogram (ECG).

Related papers

No related papers found yet.

Interventions

DRUGMatching Placebo for Deucravacitinib

DRUGZASOCITINIB

DRUGSOTYKTU 6 mg film-coated tablets

DRUGMatching Placebo for TAK-279

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
100% improvement from baseline in Psoriasis Area and Severity Index (PASI-100) response: Proportion of participants achieving PASI-100 at Week 16.	—

Secondary

Measure	Time frame
1. PASI-90 response: Proportion of participants achieving PASI-90 at Week 16., 2. Absolute PASI ≤2 response: Proportion of participants achieving PASI ≤2 at Week 16., 3. Enhanced static Physician’s Global Assessment (sPGA) response: Proportion of participants achieving an sPGA of clear (0) at Week 16., 4. PASI-100, PASI-90, sPGA 0, and absolute PASI ≤2 response at Weeks 4, 8, and 12., 5. PASI-75 and sPGA 0/1 at Weeks 4, 8, 12, and 16., 6. Change from baseline and percent change from baseline in PASI score at Weeks 4, 8, 12, and 16., 7. Incidence of treatment-emergent adverse events (TEAEs), 8. Incidence of serious adverse events (SAEs)., 9. Incidence of adverse events of special interest (AESIs)., 10. Changes in vital signs, clinical laboratory parameters, and electrocardiogram (ECG).	—

Measure

Time frame

1. PASI-90 response: Proportion of participants achieving PASI-90 at Week 16., 2. Absolute PASI ≤2 response: Proportion of participants achieving PASI ≤2 at Week 16., 3. Enhanced static Physician’s Global Assessment (sPGA) response: Proportion of participants achieving an sPGA of clear (0) at Week 16., 4. PASI-100, PASI-90, sPGA 0, and absolute PASI ≤2 response at Weeks 4, 8, and 12., 5. PASI-75 and sPGA 0/1 at Weeks 4, 8, 12, and 16., 6. Change from baseline and percent change from baseline in PASI score at Weeks 4, 8, 12, and 16., 7. Incidence of treatment-emergent adverse events (TEAEs), 8. Incidence of serious adverse events (SAEs)., 9. Incidence of adverse events of special interest (AESIs)., 10. Changes in vital signs, clinical laboratory parameters, and electrocardiogram (ECG).

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Countries

Bulgaria, Czechia, France, Latvia, Poland

Outcome results

None listed