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.

Autor: Engin B; Cerrahpaşa Faculty of Medicine, İstanbul University-Cerrahpaşa, Istanbul, Türkiye., Güler Özden M; Faculty of Medicine, Ondokuz Mayıs University, Samsun, Türkiye., Karstarlı Bakay ÖS; Faculty of Medicine, Pamukkale University, Denizli, Türkiye., Kartal SP; Etlik City Hospital, Ankara, Türkiye., Zindancı İ; Haydarpaşa Numune Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye., Çınar SL; Faculty of Medicine, Erciyes University, Kayseri, Türkiye., Dursun R; Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Türkiye., Pehlivan Ulutaş G; Haseki Training and Research Hospital, Istanbul, Türkiye., Özkök Akbulut TÖ; Haseki Training and Research Hospital, Istanbul, Türkiye., Hapa FA; Buca Seyfi Demirsoy Training and Research Hospital, Democracy University, İzmir, Türkiye., Bülbül Başkan E; Faculty of Medicine, Uludağ University, Bursa, Türkiye., Melikoğlu M; Faculty of Medicine, Atatürk University, Erzurum, Türkiye., Polat Ekinci A; İstanbul Faculty of Medicine, İstanbul University, Istanbul, Türkiye., Demirel Öğüt N; Uşak Training and Research Hospital, Uşak, Türkiye., Hızlı P; Faculty of Medicine, Balıkesir University, Balıkesir, Türkiye., Türkoğlu Z; Başakşehir Çam ve Sakura City Hospital, Istanbul, Türkiye., Küçük ÖS; Faculty of Medicine, Bezmialem Vakıf University, Istanbul, Türkiye., Topkarcı Z; Bakırköy Dr Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye., Türsen Ü; Faculty of Medicine, Mersin University, Mersin, Türkiye., Canpolat F; Etlik City Hospital, Ankara, Türkiye., Uçgun H; Faculty of Medicine, Pamukkale University, Denizli, Türkiye., Yaşar Ş; Haydarpaşa Numune Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye., Temiz SA; Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Türkiye., Doğramacı AÇ; Faculty of Medicine, Hatay Mustafa Kemal University, Hatay, Türkiye., Altuğ S; Faculty of Medicine, Demiroğlu Bilim University, Istanbul, Türkiye., Kozlu S; Department of Research and Development, Gen İlaç ve Sağlık Ürünleri A.Ş., ASO 2. Ve 3. Organize Sanayi Bolgesi, Alci OSB Mahallesi, 2013. Cadde, No: 24, 06930, Sincan, Ankara, Türkiye., Ulu N; Department of Research and Development, Gen İlaç ve Sağlık Ürünleri A.Ş., ASO 2. Ve 3. Organize Sanayi Bolgesi, Alci OSB Mahallesi, 2013. Cadde, No: 24, 06930, Sincan, Ankara, Türkiye. n.ulu@genilac.com., Serdaroğlu S; Cerrahpaşa Faculty of Medicine, İstanbul University-Cerrahpaşa, Istanbul, Türkiye.
Jazyk: angličtina
Zdroj: Dermatology and therapy [Dermatol Ther (Heidelb)] 2024 Dec; Vol. 14 (12), pp. 3337-3350. Date of Electronic Publication: 2024 Nov 22.
DOI: 10.1007/s13555-024-01301-1
Abstrakt: Introduction: Topical therapies are used in almost all patients with psoriasis. A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit-risk ratio. The present multicenter randomized double-blind vehicle-controlled parallel group phase 2 study aimed to investigate the efficacy and safety of GN-037 in patients with mild-to-moderate plaque psoriasis (MMPP).
Methods: Patients (n = 190) were randomized (2:2:1) to receive GN-037 or CP or vehicle (V) cream twice daily to a selected target body lesion for 4 weeks. The primary endpoint was treatment success defined as percentage of patients with at least two-grade improvement in Investigator's Global Assessment Score (IGA) and IGA score equal to 0 or 1 evaluated at weeks 2, 4, 6, and 8 in each arm compared with baseline. Treatment-emergent adverse events (TEAEs) and safety were evaluated throughout the study.
Results: GN-037 demonstrated statistically significant superiority over V throughout the study. At week 4, treatment success was achieved in 37.9% of patients in the GN-037 arm compared with 29.2% and 9.1% in the CP and V arms, respectively. At least two-grade improvement compared with baseline was achieved by 57.6%, 72.7%, and 80.3% of the patients in the GN-037 arm for erythema, plaque elevation, and scaling, respectively. The mean changes in affected BSA were -2.1 ± 2.9, -1.8 ± 2.4, and -0.5 ± 1.6 in the GN-037, CP, and V arms, respectively. The TEAEs were similar among the arms and the most frequently observed TEAEs were Psoriasis Area and Severity Index (PASI) increase in all arms.
Conclusions: GN-037 was more effective than V in achieving primary and all secondary endpoints throughout the study. Safety data did not reveal any new safety concerns with the combination cream product. Therefore, 4 weeks of GN-037 treatment demonstrated an excellent efficacy and safety profile in patients with MMPP.
Trial Registration Number: ClinicalTrials.gov identifier, NCT05706870.
Competing Interests: Declarations. Conflict of Interest: Nadir Ulu and Serhat Kozlu report employment on Gen İlaç ve Sağlık Ürünleri A.Ş. Burhan Engin, Müge Güler Özden, Özge Sevil Karstarlı Bakay, Selda Pelin Kartal, İlkin Zindancı, Salih Levent Çınar, Recep Dursun, Gizem Pehlivan Ulutaş, Tuğba Özkök Akbulut, Fatma Aslı Hapa, Emel Bülbül Başkan, Mehmet Melikoğlu, Algün Polat Ekinci, Neslihan Demirel Öğüt, Pelin Hızlı, Zafer Türkoğlu, Özlem Su Küçük, Zeynep Topkarcı, Ümit Türsen, Filiz Canpolat, Hanife Uçgun, Şirin Yaşar, Selami Aykut Temiz, Asena Çiğdem Doğramacı, Sedat Altuğ and Server Serdaroğlu have nothing to disclose. Ethical Approval: The trial was carried out according to the ethical standards of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines and its revisions. The study protocol was approved by the Ethics Committee for Clinical Trials of Istanbul University-Cerrahpasa, Istanbul, Turkey, and the Republic of Turkey. Written informed consent was provided from all patients before enrollment.
(© 2024. The Author(s).)
Databáze: MEDLINE
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