Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis
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
Timeline
- Start
- 2022-12-07
- Primary completion
- 2024-01-04
- Completion
- 2024-03-03
Outcome
Met primary endpoint
paper GN-037 demonstrated statistically significant superiority over V throughout the study. PMID 39578347 ↗
paper GN-037 was more effective than V in achieving primary and all secondary endpoints throughout the study. PMID 39578347 ↗
release “Yenilikçi topikal kremimiz ile gerçekleştirdiğimiz Faz 2 klinik araştırmamızda tüm primer ve sekonder sonlanım noktaları bakımından GN-037 kreminin plaseboya göre daha üstün sonuçlar sağladığı” com.tr ↗
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GN-037 | Unknown | — | Topical |
| Comparator | clobetasol propionate | Small molecule | — | Topical |