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
Engin, Burhan, Ozden, Muge Guler, Bakay, Ozge Sevil Karstarli, Kartal, Selda Pelin, Zindanci, Ilkin, Cinar, Salih Levent, Dursun, Recep, Pehlivan Ulutas, Gizem, Akbulut, Tugba Ozkok Ozkok, Hapa, Fatma Asli, Bulbul Baskan, Emel, Melikoglu, Mehmet, Polat Ekinci, Algun, Demirel Ogut, Neslihan, Hizli, Pelin, Turkoglu, Zafer, Kucuk, Ozlem Su, Topkarci, Zeynep, Tursen, Umit, Canpolat, Filiz, Ucgun, Hanife, Yasar, Sirin, Temiz, Selami Aykut, Dogramaci, Asena Cigdem, Altug, Sedat, Kozlu, Serhat, Ulu, Nadir, Serdaroglu, Server
IntroductionTopical 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).MethodsPatients (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.ResultsGN-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.ConclusionsGN-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 numberClinicalTrials.gov identifier, NCT05706870.
- Dergi
- DERMATOLOGY AND THERAPY
- Yıl
- 2024
- Cilt
- 14
- Sayı
- 12
- Sayfa
- 3337-3350
- ISSN
- 2193-8210
- eISSN
- 2190-9172
- DOI
- 10.1007/s13555-024-01301-1
- WoS UID
- WOS:001360940200001