A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis

Conditions

Plaque Psoriasis

Brief summary

Proportion of participants achieving PASI 75 at Week 12

Detailed description

1. Proportion of participants achieving: • an sPGA score of 0 or 1 with ≥2 grade improvement from baseline at Week 12 • ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score at all scheduled timepoints • an sPGA score of 0 or 1 at all scheduled timepoints • Mean change and percent change from baseline in PASI score at all scheduled timepoints • Mean change and percent change from baseline in the percentage of BSA affected at all scheduled timepoints, 2. Summary of safety data, including number and proportion of: • TEAEs • SAEs • discontinuations due to TEAEs, 3. Measurement of plasma concentration of LY4100511 at scheduled timepoints to evaluate steady state maximum concentration (Cmax,ss) and trough concentration (Ctrough,ss) and associated intra-individual variability

Related papers

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Interventions

DRUGPlacebo tablets will be the same size

DRUGshape

DRUGand color as the active tablets and will consist of the compendial excipients present in the active tablets. Placebo tablets are supplied in the same packaging configuration as the active tablets.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving PASI 75 at Week 12	—

Secondary

Measure	Time frame
1. Proportion of participants achieving: • an sPGA score of 0 or 1 with ≥2 grade improvement from baseline at Week 12 • ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score at all scheduled timepoints • an sPGA score of 0 or 1 at all scheduled timepoints • Mean change and percent change from baseline in PASI score at all scheduled timepoints • Mean change and percent change from baseline in the percentage of BSA affected at all scheduled timepoints, 2. Summary of safety data, including number and proportion of: • TEAEs • SAEs • discontinuations due to TEAEs, 3. Measurement of plasma concentration of LY4100511 at scheduled timepoints to evaluate steady state maximum concentration (Cmax,ss) and trough concentration (Ctrough,ss) and associated intra-individual variability	—

Measure

Time frame

1. Proportion of participants achieving: • an sPGA score of 0 or 1 with ≥2 grade improvement from baseline at Week 12 • ≥50%, ≥75%, ≥90%, and 100% reduction in PASI score at all scheduled timepoints • an sPGA score of 0 or 1 at all scheduled timepoints • Mean change and percent change from baseline in PASI score at all scheduled timepoints • Mean change and percent change from baseline in the percentage of BSA affected at all scheduled timepoints, 2. Summary of safety data, including number and proportion of: • TEAEs • SAEs • discontinuations due to TEAEs, 3. Measurement of plasma concentration of LY4100511 at scheduled timepoints to evaluate steady state maximum concentration (Cmax,ss) and trough concentration (Ctrough,ss) and associated intra-individual variability

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Countries

Czechia, Germany, Hungary, Poland

Outcome results

None listed