Overall trial status: Ended
Trial title: 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
Medical conditions: Plaque Psoriasis
Status in each country: Spain:Ended, Poland:Ended, Hungary: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 ≥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 end point: • 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
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: 206
Sponsor: DICE Therapeutics Inc.
Sponsor type: Pharmaceutical company
Trial product: DC-806 Placebo tablets, DC-806, DC-806, DC-806, DC-806
Results posted: Yes
Overall decision date: 17/08/2023
Countries decision date: HU: 18/08/2023, PL: 21/08/2023, ES: 18/08/2023, DE: 21/08/2023, CZ: 17/08/2023
Last updated date: 22/04/2024
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