This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago
A total of 190 patients aged between 18-65 years diagnosed with plaque psoriasis are planned to be included in the study. The study consists of three periods: Screening period: Within 4 weeks before baseline visit (-28 days to 0 days) Treatment period: 4 weeks Follow-up period with observation: 4 weeks The study is planned to last a maximum of 12 weeks for each patient. Study consists of 5 visits: baseline (day 1), week 2, week 4, week 6 and week 8 which is a follow-up period with observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
190
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Balıkesir University Faculty of Medicine
Balıkesir, Turkey (Türkiye)
Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm.
Improvement will be evaluated as the number and percent of patients with at least 2 points improvement in IGA score, and IGA score equating to 0 or 1.
Time frame: 28 days
Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm.
Target plaque area (cm2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm). A negative percent change indicates a mild disease.
Time frame: 28 days
Improvement in Psoriasis Area Severity Index (PASI) from baseline at weeks 2, 4, 6 and 8 in each arm. Improvement will be evaluated as the number and percent of patients with ≥75% improvement in PASI score.
The PASI scoring system takes into account the overall severity of erythema (redness), induration (plaque thickness) and scaling, and the extent of %Body Surface Area affected with psoriasis. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time frame: 28 days
Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm.
For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates better outcome.
Time frame: 28 days
Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm.
Improvement will be evaluated as the number and percent of patients whose target lesion erythema, plaque thickness and scaling score improvement at least 2 points at week 2, 4, 6 and 8 compared to baseline in each arm. Additionally, at which week at least 50% improvement in the target lesion healing is observed in each arm will be evaluated. Target plaque area (cm2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm).
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Uludag University Faculty of Medicine
Bursa, Turkey (Türkiye)
Pamukkale University Faculty of Medicine
Denizli, Turkey (Türkiye)
Ataturk University Research Hospital
Erzurum, Turkey (Türkiye)
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye)
Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey (Türkiye)
Bezmialem Vakif University Faculty of Medicine
Istanbul, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey (Türkiye)
Istanbul Haseki Training and Research Hospital
Istanbul, Turkey (Türkiye)
...and 8 more locations
Time frame: .28 days
Improvement in Dermatology Life Quality Index (DLQI)
Improvement in DLQI at weeks 4 and 8 compared to baseline.
Time frame: 28 days
Safety, Adverse Events and Serious Adverse Events
Safety will be evaluated as the number and ratio of patients with adverse events and serious adverse events in each arm. Additionally, number of adverse events which resulted in discontinuation of the study treatment in each arm will be evaluated
Time frame: 56 days