Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT05706870
- Lead Sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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Male and female patients between the ages of 18-65
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Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.
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Patients with negative SARS-CoV-2 PCR test result
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Patients 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 enrolment.
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Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screening visit [Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment]
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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.]
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Patients who received the last psoriasis treatment 4 weeks or before
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Patients 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.
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Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study
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Female 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.
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Patients who can comply with all scheduled visits, laboratory tests, and other study procedures
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Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
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Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels
- Patients with a known sensitivity/hypersensitivity to any component of the drugs to be used in the study
- Pregnant or lactating or female patients with a positive pregnancy test
- Patients who are resistant/unresponsive to corticosteroids
- Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens
- Patients 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 sites
- Patients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeks
- Patients who received biologic therapy for psoriasis in the last 3 months
- Immunosuppressive 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 year
- Patients 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 team
- Patients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrently
- Patients 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo cream will be applied in 2:2:1 ratio Psoriatic patients will receive placebo cream twice daily on a selected body target lesion Placebo cream will be applied as a thin film layer for 4 weeks. GN-037 cream GN-037 Psoriatic patients will receive GN-037 cream in 2:2:1 ratio Psoriatic patients will receive GN-037 cream twice daily on a selected body target lesion GN-037 cream will be applied as a thin film layer for 4 weeks. Clobetasol 17-propionate cream Clobetasol 17-propionate Clobetasol 17-propionate cream will be applied in 2:2:1 ratio Psoriatic patients will receive clobetasol 17-propionate cream twice daily on a selected body target lesion Clobetasol 17-propionate will be applied as a thin film layer for 4 weeks.
- Primary Outcome Measures
Name Time Method Improvement in Investigator Global Assessment (IGA) score evaluated at weeks 2, 4, 6 and 8 in each arm. 28 days 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.
- Secondary Outcome Measures
Name Time Method 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. 28 days 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.
Improvement in Dermatology Life Quality Index (DLQI) 28 days Improvement in DLQI at weeks 4 and 8 compared to baseline.
Mean change in %BSA affected from baseline at weeks 2, 4, 6 and 8 in each arm. 28 days 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.
Mean change in in total plaque severity score (TPSS) from baseline at week 2, 4, 6 and 8 in each arm. 28 days 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.
Improvement in target lesion healing from baseline at weeks 2, 4, 6 and 8 in each arm. .28 days 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).Safety, Adverse Events and Serious Adverse Events 56 days 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
Trial Locations
- Locations (18)
Uludag University Faculty of Medicine
🇹🇷Bursa, Turkey
Ataturk University Research Hospital
🇹🇷Erzurum, Turkey
Pamukkale University Faculty of Medicine
🇹🇷Denizli, Turkey
Erciyes University Faculty of Medicine
🇹🇷Kayseri, Turkey
Istanbul Haseki Training and Research Hospital
🇹🇷Istanbul, Turkey
Samsun Ondokuz Mayis University Faculty of Medicine
🇹🇷Samsun, Turkey
Haydarpasa Numune Training and Research Hospital
🇹🇷Istanbul, Turkey
Uşak Training and Research Hospital
🇹🇷Uşak, Turkey
Ankara Etlik City Hospital
🇹🇷Ankara, Turkey
Balıkesir University Faculty of Medicine
🇹🇷Balıkesir, Turkey
Istanbul University Cerrahpasa Faculty of Medicine
🇹🇷Istanbul, Turkey
Basaksehir Cam and Sakura City Hospital
🇹🇷Istanbul, Turkey
Bezmialem Vakif University Faculty of Medicine
🇹🇷Istanbul, Turkey
Istanbul University Istanbul Faculty of Medicine
🇹🇷Istanbul, Turkey
University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital
🇹🇷Istanbul, Turkey
Necmettin Erbakan University Meram Faculty of Medicine
🇹🇷Konya, Turkey
İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital
🇹🇷İzmir, Turkey
Mersin University Faculty of Medicine
🇹🇷Mersin, Turkey