Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Monitor CRO | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GN-037 cream | Experimental | 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 | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GN-037 | Drug | GN-037 |
| |
| Clobetasol 17-propionate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
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 enrolment.
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]
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nadir Ulu, MD PhD | Gen Ilac | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | Turkey (Türkiye) | ||||
| Balıkesir University Faculty of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39578347 | Derived | Engin B, Guler Ozden M, Karstarli Bakay OS, Kartal SP, Zindanci I, Cinar SL, Dursun R, Pehlivan Ulutas G, Ozkok Akbulut TO, Hapa FA, Bulbul Baskan E, Melikoglu M, Polat Ekinci A, Demirel Ogut N, Hizli P, Turkoglu Z, Kucuk OS, Topkarci Z, Tursen U, Canpolat F, Ucgun H, Yasar S, Temiz SA, Dogramaci AC, Altug S, Kozlu S, Ulu N, Serdaroglu S. A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Dec;14(12):3337-3350. doi: 10.1007/s13555-024-01301-1. Epub 2024 Nov 22. | |
| 37300792 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Clobetasol 17-propionate |
|
| Placebo | Drug | Placebo |
|
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. |
| 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. | 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). | .28 days |
| Improvement in Dermatology Life Quality Index (DLQI) | Improvement in DLQI at weeks 4 and 8 compared to baseline. | 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 | 56 days |
| Balıkesir |
| Turkey (Türkiye) |
| 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 | 34786 | 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) |
| Istanbul University Istanbul Faculty of Medicine | Istanbul | Turkey (Türkiye) |
| University of Health Sciences Bakırkoy Dr. Sadi Konuk Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| İzmir Democracy University Buca Seyfi Demirsoy Training And Research Hospital | Izmir | Turkey (Türkiye) |
| Erciyes University Faculty of Medicine | Kayseri | 38110 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Faculty of Medicine | Konya | Turkey (Türkiye) |
| Mersin University Faculty of Medicine | Mersin | Turkey (Türkiye) |
| Samsun Ondokuz Mayis University Faculty of Medicine | Samsun | Turkey (Türkiye) |
| Uşak Training and Research Hospital | Uşak | Turkey (Türkiye) |
| Derived |
| Sezer Z, Inal A, Cinar SL, Mazicioglu MM, Altug S, Karasulu HY, Diril M, Mehmetoglu Al A, Kozlu S, Ulu N. Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial. Dermatol Ther (Heidelb). 2023 Jul;13(7):1489-1501. doi: 10.1007/s13555-023-00939-7. Epub 2023 Jun 10. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided