Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis

This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerabilityGN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago

Inclusion Criteria:Male and female patients between the ages of 18-65Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.Patients with negative SARS-CoV-2 PCR test resultPatients who were diagnosed with mild or moderate plaque psoriasis at least 6 months ago by a dermatologist and whose diagnosis was confirmed according to the clinical judgment of the research physician at the time of enrollment.Patients with a Physician's Global Assessment (IGA) score of 3 or 4 at the screening visit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment]Patients with plaque psoriasis lesions covering a body surface area (BSA) of at least 3% to 12% [Face, scalp, palms, soles, axillae, and intertriginous areas will be excluded from this assessment.]Patients who received the last psoriasis treatment 4 weeks or beforePatients who are confirmed to be healthy by medical history and physical examination and who do not have any clinically significant disease/condition other than plaque psoriasis that, at the discretion of the investigator, could affect the study evaluation.Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the studyFemale patients: Patients who had a negative pregnancy test at the screening visit, did not breastfeed, did not plan pregnancy during the study, and agreed to use an effective method of contraception until the end of the study.Male patients: Patients who agreed to use an effective method of contraception for the duration of the study.Patients who can comply with all scheduled visits, laboratory tests, and other study proceduresPatients with normal adrenocorticotropic hormone (ACTH) stimulation testPatients with normal dihydroepiandrostenedione sulfate (DHEAS) levelsExclusion Criteria:Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the studyPregnant or lactating or female patients with a positive pregnancy testPatients who are resistant/unresponsive to corticosteroidsPatients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsensPatients with other inflammatory skin disease (eg, atopic dermatitis, contact dermatitis, eczema, tinea corporis) that, in the opinion of the investigative physician, may affect study evaluations at the targeted treatment sitesPatients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeksPatients who received biologic therapy for psoriasis in the last 3 monthsImmunosuppressive or immunocompromised patients (patients who have taken immunosuppressive drugs in the last 2 months will also be excluded)Patients who have received any cancer treatment in the last 1 yearPatients with severe hypertension (systolic blood pressure [SBP] > 160 mmHg or diastolic blood pressure [DBP] > 100 mmHg)Patients who cannot comply with the study procedures/rules and cannot be in harmony with the research teamPatients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrentlyPatients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPA axis)Patients using products containing dihydroepiandrostenedione (DHEA) or dihydroepiandrostenedione sulfate (DHEAS) in the last 1 month