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
Özet
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.
Anahtar kelimeler
Atıf için künye
ENGİN, B., Güler Özden, M., Karstarlı Bakay, Ö. S., Kartal, S. P., Zindancı, İ., ÇINAR, S. L., Dursun, R., Pehlivan Ulutaş, G., Özkök Akbulut, T. Ö., Hapa, F. A., Bülbül Başkan, E., Melikoğlu, M., Polat Ekinci, A., Demirel Öğüt, N., Hızlı, P., Türkoğlu, Z., Küçük, Ö. S., Topkarcı, Z., Türsen, Ü., … Serdaroğlu, S. (2024). 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. Dermatology and Therapy, 14(12), 3337–3350. https://doi.org/10.1007/s13555-024-01301-1
BibTeX
@article{engin2024-224615,
author = {ENGİN, BURHAN and Güler Özden, Müge and Karstarlı Bakay, Özge Sevil and Kartal, Selda Pelin and Zindancı, İlkin and ÇINAR, SALİH LEVENT and Dursun, Recep and Pehlivan Ulutaş, Gizem and Özkök Akbulut, Tuğba Özkök and Hapa, Fatma Aslı and Bülbül Başkan, Emel and Melikoğlu, Mehmet and Polat Ekinci, Algün and Demirel Öğüt, Neslihan and Hızlı, Pelin and Türkoğlu, Zafer and Küçük, Özlem Su and Topkarcı, Zeynep and Türsen, Ümit and Canpolat, Filiz and Uçgun, Hanife and Yaşar, Şirin and Temiz, Selami Aykut and Doğramacı, Asena Çiğdem and Altuğ, Sedat and Kozlu, Serhat and Ulu, Nadir and Serdaroğlu, Server},
title = {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},
journal = {Dermatology and Therapy},
year = {2024},
volume = {14},
number = {12},
pages = {3337--3350},
issn = {2193-8210},
doi = {10.1007/s13555-024-01301-1},
url = {https://akademik.atauni.edu.tr/yayinlar/224615-a-multicenter-randomized-double-blind-vehicle-controlled-parallel-group-phase-2}
}