Overall trial status: Ended
Trial title: 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
Medical conditions: Plaque Psoriasis
Status in each country: Hungary:Ended, Poland:Ended, Czechia:Ended, Germany:Ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Proportion of participants achieving PASI 75 at Week 12
Secondary end point: 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
Age of participants: 65+ years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 134
Sponsor: Dice Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: Placebo tablets will be the same size, shape, and 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.
Results posted: Yes
Overall decision date: 23/01/2025
Countries decision date: PL: 27/01/2025, HU: 24/01/2025, DE: 24/01/2025, CZ: 23/01/2025
Last updated date: 06/10/2025
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