Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
Study Details
Study Description
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 tolerabilityGN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 28 days 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 6 visits: baseline (day 1), week 2 and week 4, and week 6 and week 8, which is a follow-up period with observation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GN 037 cream Psoriatic patients will receive GN037 cream in 2 to 2 to 1 ration Application will be done twice daily, to a selected body target lesion Psoriatic patients will receive GN037 cream twice daily, GN037 cream will be applied as thin film layer, for 4 weeks. |
Drug: GN037
GN037
|
| Active Comparator: Clobetasol 17-propianate Clobetasol 17-propianate cream will be applied in 2 to 2 to 1 ration Application will be done twice daily, to a selected body target lesion Psoriatic patients will receive Clobetasol 17 propionate cream twice daily, to a selected body target lesion Clobetasol 17-propianate will be applied as thin film layer, for 4 weeks. |
Drug: Clobetasol 17-Propionate Cream
Clobetasol 17-Propionate
|
| Placebo Comparator: Placebo Placebo cream will be applied in 2 to 1 ratio twice daily, Application will be done twice daily, to a selected body target lesion Psoriatic patients will receive placebo cream twice daily, to a selected body target lesion Cream will be applied as thin film layer, for 4 weeks. |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Number and percentage of patients that showed at least 2 points improvement in Physician's Global Assessment (PGA) score at week 4 compared to baseline in each arm [28 days]
The PGA is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
- The number and percentage of patients whose target lesion healing scores improved by at least 2 points at week 4 compared to baseline 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 mild disease
Secondary Outcome Measures
- Physician's Global Assessment (PGA) - Number and percentage of patients with an PGA score of 0 or 1 and mean change in PGA score at each visit - Number and percentage of patients with an PGA score of 0 or 1 of at week 4 - Number of patients with an [28 days]
Higher PGA scores represent more severe disease.
- The mean change in %BSA affected from baseline at each visit [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 mild disease
- Difference in Psoriasis Area Severity Index (PASI) from baseline at week 4 in each arm [28 days]
The PASI scoring system takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, 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.
- Difference in least squares mean percent change from baseline at week 4 in total plaque severity score (TPSS) 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female patients between the ages of 18-65
-
Patients 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 result
-
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 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 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.
-
Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study
-
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.
-
Patients who can comply with all scheduled visits, laboratory tests, and other study procedures
-
Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
-
Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ankara Etlik City Hospital | Ankara | Turkey | ||
| 2 | Uludag University Faculty of Medicine | Bursa | Turkey | ||
| 3 | Pamukkale University Faculty of Medicine Hospital | Denizli | Turkey | ||
| 4 | Hatay Mustafa Kemal University Faculty of Medicine Hospital | Hatay | Turkey | ||
| 5 | Istanbul University Cerrahpasa Faculty of Medicine | Istanbul | Turkey | 34786 | |
| 6 | Bezmialem Vakif University Faculty of Medicine | Istanbul | Turkey | ||
| 7 | Istanbul Haseki Training and Research Hospital | Istanbul | Turkey | ||
| 8 | Istanbul Umraniye Training and Research Hospital | Istanbul | Turkey | ||
| 9 | Istanbul University Istanbul Faculty of Medicine | Istanbul | Turkey | ||
| 10 | University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital | Istanbul | Turkey | ||
| 11 | Erciyes University Faculty of Medicine | Kayseri | Turkey | 38110 | |
| 12 | Samsun Ondokuz Mayis University Faculty Of Medicine | Samsun | Turkey |
Sponsors and Collaborators
- GEN İlaç ve Sağlık Ürünleri A.Ş.
- Monitor CRO
Investigators
- Study Chair: Nadir Ulu, MD PhD, Gen Ilac
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MON886.151.7