A Multicenter, Randomized, Double-blind, Placebo- controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis

Conditions

Plaque Psoriasis

Brief summary

• Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75) at Week 12 • Incidence proportion of TEAEs, SAEs, and TEAEs leading to discontinuation

Detailed description

• Proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12 • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12, • Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at all scheduled timepoints • Proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints, • Change and percent change from Baseline in PASI score at all scheduled timepoints • Change and percent change from Baseline in the percentage of BSA affected at all scheduled timepoints • Measurement of plasma concentration of DC-806 at scheduled timepoints

Related papers

No related papers found yet.

Interventions

DRUGDC-806 Placebo tablets

DRUGDC-806

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Proportion of participants achieving ≥75% reduction in Psoriasis Area of Severity Index score (PASI-75) at Week 12 • Incidence proportion of TEAEs, SAEs, and TEAEs leading to discontinuation	—

Secondary

Measure	Time frame
• Proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12 • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12, • Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at all scheduled timepoints • Proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints, • Change and percent change from Baseline in PASI score at all scheduled timepoints • Change and percent change from Baseline in the percentage of BSA affected at all scheduled timepoints • Measurement of plasma concentration of DC-806 at scheduled timepoints	—

Measure

Time frame

• Proportion of participants in each DC-806 treatment group achieving PASI-75 at Week 12 • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12, • Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at all scheduled timepoints • Proportion of participants achieving an sPGA score of 0 or 1 at all scheduled timepoints, • Change and percent change from Baseline in PASI score at all scheduled timepoints • Change and percent change from Baseline in the percentage of BSA affected at all scheduled timepoints • Measurement of plasma concentration of DC-806 at scheduled timepoints

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Countries

Czechia, Germany, Hungary, Poland, Spain

Outcome results

None listed