Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
NCT ID: NCT05706870
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2022-12-07
2024-03-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GN-037 cream
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.
GN-037
GN-037
Clobetasol 17-propionate cream
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.
Clobetasol 17-propionate
Clobetasol 17-propionate
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.
Placebo
Placebo
Interventions
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GN-037
GN-037
Clobetasol 17-propionate
Clobetasol 17-propionate
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Patients who can give their written informed consent prior to initiating any evaluation or procedure related to the study.
3. Patients with negative SARS-CoV-2 PCR test result
4. 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.
5. Patients with a Investigator Global Assessment (IGA) score of 2 or 3 at the screening visit \[Face, scalp, palms, soles, armpits, and intertriginous areas will be excluded from this assessment\]
6. Patients with plaque psoriasis lesions covering a body surface area (BSA) of at least 3% to 12% \[Face, scalp, palms, soles, axillae, and intertriginous areas will be excluded from this assessment.\]
7. Patients who received the last psoriasis treatment 4 weeks or before
8. 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.
9. Patients who can protect the lesion areas from ultraviolet (UV) rays (natural or artificial) during the study
10. 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.
11. Patients who can comply with all scheduled visits, laboratory tests, and other study procedures
12. Patients with normal adrenocorticotropic hormone (ACTH) stimulation test
13. Patients with normal dihydroepiandrostenedione sulfate (DHEAS) levels
Exclusion Criteria
2. Pregnant or lactating or female patients with a positive pregnancy test
3. Patients who are resistant/unresponsive to corticosteroids
4. Patients with psoriasis (eg guttate, erythrodermic, exfoliative or pustular) that, in the opinion of the investigating physician, resolves spontaneously or rapidly worsens
5. 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
6. Patients who received phototherapy, photochemotherapy, systemic or local treatment for psoriasis or used systemic anti-inflammatory agents in the last 4 weeks
7. Patients who received biologic therapy for psoriasis in the last 3 months
8. Immunosuppressive or immunocompromised patients (patients who have taken immunosuppressive drugs in the last 2 months will also be excluded)
9. Patients who have received any cancer treatment in the last 1 year
10. Patients with severe hypertension (systolic blood pressure \[SBP\] \> 160 mmHg or diastolic blood pressure \[DBP\] \> 100 mmHg)
11. Patients who cannot comply with the study procedures/rules and cannot be in harmony with the research team
12. Patients who have participated in another clinical trial in the last 2 months or who are taking part in another clinical trial concurrently
13. Patients with a known abnormality of the hypothalamus-pituitary-adrenal axis (HPA axis)
14. Patients using products containing dihydroepiandrostenedione (DHEA) or dihydroepiandrostenedione sulfate (DHEAS) in the last 1 month
18 Years
65 Years
ALL
No
Sponsors
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Monitor CRO
INDUSTRY
GEN İlaç ve Sağlık Ürünleri A.Ş.
INDUSTRY
Responsible Party
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Principal Investigators
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Nadir Ulu, MD PhD
Role: STUDY_CHAIR
Gen Ilac
Locations
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Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Balıkesir University Faculty of Medicine
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, , 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, , 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)
Countries
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References
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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.
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.
Other Identifiers
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MON886.151.7
Identifier Type: -
Identifier Source: org_study_id
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