The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.
Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials. The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following: * Screening period (initials assessment and eligibility scoring) * Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing * Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed * Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed * Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed * Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed * Week 14: final safety assessments including vital signs, body temperature, and clinical labs
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Lycera Investigational Site
Carmel, Indiana, United States
Lycera Investigational Site
Andover, Massachusetts, United States
Lycera Investigational Site
Fridley, Minnesota, United States
Lycera Investigational Site
East Windsor, New Jersey, United States
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
This endpoint was calculated in each treatment group by taking the Week 12 PASI score and subtracting the baseline PASI and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
Time frame: Baseline to Week 12
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
This endpoint calculated the number of subjects achieving a ≥ 75% reduction in their Week 12 PASI score compared to their baseline PASI. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
Time frame: Baseline to Week 12
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
Mean percent change from baseline to Week 12 in %BSA was calculated by taking the Week 12 %BSA and subtracting the baseline %BSA then dividing by the baseline %BSA and multiplying by 100. The mean percent change from baseline to Week 12 in each treatment group were compared using analysis of covariance with treatment as a factor and baseline as a covariate.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lycera Investigational Site
High Point, North Carolina, United States
Lycera Investigational Site
Broomall, Pennsylvania, United States
Lycera Investigational Site
Norfolk, Virginia, United States
Time frame: Baseline to Week 12
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
This endpoint is number of subjects who achieved a score of 0 or 1 on the static IGA at week 12. The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared \[no plaque elevation, erythema or scaling, hyperpigmentation may be present\]; 1 = Minimal \[minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over \< 5% of lesion\]; 2 = Mild \[mild plaque elevation (=0.5mm), light red coloration, fine scale predominates\]; 3 = Moderate \[moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates\]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates\]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates\].
Time frame: 12 weeks
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
This endpoint is based on number of subjects who achieved a 2 step reduction in the static IGA at week 12 (ie, a score of 5 at baseline to a score of 3 or less at Week 12). The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared \[no plaque elevation, erythema or scaling, hyperpigmentation may be present\]; 1 = Minimal \[minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over \< 5% of lesion\]; 2 = Mild \[mild plaque elevation (=0.5mm), light red coloration, fine scale predominates\]; 3 = Moderate \[moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates\]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates\]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates\].
Time frame: 12 weeks