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01
Overview
Phase 2, randomised, double-blind trial of SRT2104 in plaque psoriasis (3 cohorts), sponsored by GSK. Primary endpoints: Assessment of Clinical Activity by Improvement Score (Using Krueger Criteria) at 12 weeks, Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) and 2 more. Started Jun 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Cohort 1 (250mg)
SRT2104 250mg or Placebo (4:1)
Cohort 2 (500mg)
SRT2104 500mg or Placebo (4:1)
Cohort 3 (1000mg)
SRT2104 1000mg or Placebo (4:1)
03
Who it enrols
Adults with stable, moderate to severe plaque-type psoriasis (PASI >= 10, BSA >= 10%) who are candidates for systemic therapy. Excludes patients with recent systemic/topical treatments, active infections, significant organ dysfunction, or history of malignancy.
04
Endpoints
Primary
Assessment of Clinical Activity by Improvement Score (Using Krueger Criteria)
Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)
Number of Participants With Hematology and Coagulation Abnormalities of Potential Clinical Concern
Number of Participants With Abnormal Electrocardiogram (ECG) Values
Secondary
Number of Participants With Clinical Activity in Psoriasis Area and Severity Index (PASI) Score
Summary of Physician's Global Assessment (PGA) Score
Area Under Curve (AUC) of 12 Weeks of Dosing
Maximum Plasma Concentration (Cmax)
Change From Baseline in Fibroblast Growth Factor 21 (FGF21)
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
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