Dermatology and Therapy (Nov 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

  • Burhan Engin,
  • Müge Güler Özden,
  • Özge Sevil Karstarlı Bakay,
  • Selda Pelin Kartal,
  • İlkin Zindancı,
  • Salih Levent Çınar,
  • Recep Dursun,
  • Gizem Pehlivan Ulutaş,
  • Tuğba Özkök 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,
  • Serhat Kozlu,
  • Nadir Ulu,
  • Server Serdaroğlu

DOI
https://doi.org/10.1007/s13555-024-01301-1
Journal volume & issue
Vol. 14, no. 12
pp. 3337 – 3350

Abstract

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Abstract 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.

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