A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 Cream Used in the Treatment of Mild to Moderate Plaque Psoriasis

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

开始日期2022-12-07

申办/合作机构

Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

[+1]

NCT05428202

/ Completed临床1期IIT

Phase I Study to Assess Safety, Tolerability and Clinical Benefits of Topically Applied GN-037 Cream in Healthy Volunteers and Patients Diagnosed With Psoriasis

In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.

开始日期2022-03-28

申办/合作机构

Tc Erciyes University

[+1]

100 项与尿素/水杨酸/维A酸/丙酸氯倍他索相关的临床结果

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100 项与尿素/水杨酸/维A酸/丙酸氯倍他索相关的转化医学

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100 项与尿素/水杨酸/维A酸/丙酸氯倍他索相关的专利（医药）

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2024-12-01·Dermatology and Therapy

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

Article

作者: Altuğ, Sedat ; Hapa, Fatma Aslı ; Yaşar, Şirin ; Çınar, Salih Levent ; Canpolat, Filiz ; Özkök Akbulut, Tuğba Özkök ; Topkarcı, Zeynep ; Türkoğlu, Zafer ; Melikoğlu, Mehmet ; Temiz, Selami Aykut ; Ulu, Nadir ; Demirel Öğüt, Neslihan ; Bülbül Başkan, Emel ; Küçük, Özlem Su ; Türsen, Ümit ; Serdaroğlu, Server ; Pehlivan Ulutaş, Gizem ; Zindancı, İlkin ; Polat Ekinci, Algün ; Karstarlı Bakay, Özge Sevil ; Kozlu, Serhat ; Güler Özden, Müge ; Kartal, Selda Pelin ; Hızlı, Pelin ; Dursun, Recep ; Engin, Burhan ; Doğramacı, Asena Çiğdem ; Uçgun, Hanife

AbstractIntroductionTopical 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.

2023-07-01·Dermatology and Therapy

Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial

Article

作者: Cinar, Salih L ; Mehmetoglu Al, Ayca ; Karasulu, Hatice Y ; Sezer, Zafer ; Altug, Sedat ; Inal, Ahmet ; Kozlu, Serhat ; Ulu, Nadir ; Mazicioglu, Mustafa M ; Diril, Mine

INTRODUCTIONPsoriasis is a common skin disorder associated with physical and psychological burdens. Visible disfiguration can trigger a negative reaction which can cause much of the readily measurable psychological burden of the disease. Although many biological treatments provide some success in the initial clearance of lesions, there is a dispute about the long-term maintenance of the disease, as no current biological treatment has been shown to be curative. Topical therapies are still the most widely used agents as first-line and maintenance treatment for psoriasis. The present study aimed to investigate the safety, tolerability, and, to some extent, efficacy of GN-037 cream in patients with psoriasis and healthy volunteers.METHODSA randomized, double-blind, single-center, placebo-controlled phase 1 clinical study was conducted to evaluate the safety, tolerability, and clinical efficacy of GN-037 cream topically applied twice daily for 2 weeks in healthy subjects (n = 12) and patients (n = 6) diagnosed with plaque-type psoriasis. Six healthy subjects received placebo. Patients with plaque psoriasis were evaluated by a dermatologist, and Physician Global Assessment (PGA) score was required to be ≥ 3 (moderate psoriasis) at screening.RESULTSA total of 31 adverse events (AEs) occurred in 13 participants during the study: 9 AEs in healthy subjects receiving GN-037 cream, 3 AEs in healthy subjects receiving placebo, and 1 AE in one psoriatic patient. The most frequently reported AEs were reactions at the application site, including erythema, exfoliation, pruritus, and burning sensation. During the baseline evaluation, one patient had a PGA score of 3 (moderate) and five patients had a PGA score of 4 (severe). On day 14, in treatment, four patients experienced second grade and two patients third grade improvements compared with baseline, indicating a shift of patients from moderate and severe disease to mild disease and to almost clear (score 2 or 1). There were slight increases in plasma tumor necrosis factor (TNF)-α, interleukin-17 (IL-17) and interleukin-23 (IL-23) levels in both healthy volunteers and patients throughout the study, as compared with baseline.CONCLUSIONThe results of this phase 1 trial conducted in 18 healthy volunteers and 6 patients with plaque psoriasis demonstrated a favorable safety and tolerability profile for GN-037; therefore, further clinical development of GN-037 in a phase 2 clinical trial has been initiated in patients with mild to moderate plaque psoriasis (NCT05706870).TRIAL REGISTRATION NUMBERNCT05428202.

项与尿素/水杨酸/维A酸/丙酸氯倍他索相关的新闻（医药）

2024-09-25

·BioSpace

GEN Announces Positive Phase 2 Clinical Trial Results for GN-037 Topical Cream in Patients With Mild to Moderate Plaque Psoriasis

ANKARA, TURKEY / ACCESSWIRE / September 25, 2024 / GEN Pharmaceuticals (GENIL.IS), a leading Turkish pharmaceutical company, has announced the positive results of its Phase 2 clinical trial evaluating the safety and efficacy of its investigational drug, GN-037 topical cream , in treating mild to moderate plaque psoriasis. The findings were presented at Amsterdam’s European Academy of Dermatology and Venereology (EADV) 2024 Congress . GEN Pharmaceuticals GEN Pharmaceuticals Manufacturing Facility This multicenter, randomized, double-blind, placebo-controlled Phase 2 study involved 190 patients across 19 clinical centers in Türkiye. Patients were treated with GN-037 , clobetasol 17-propionate , or placebo twice daily for four weeks, followed by an additional four-week observation period. The study demonstrated GN-037’s statistically significant superiority in reducing psoriasis symptoms compared to placebo, positioning it as a promising new treatment option for psoriasis patients worldwide. Key Findings: The GN-037 Phase 2 trial met the primary endpoint: treatment success,defined as the percentage of patients with at least a 2-grade improvement in Investigator’s Global Assessment (IGA) score and achieving an IGA score of 0 or 1. 37.9% of patients treated with GN-037 achieved treatment success at week four compared to 9.1% in the placebo group ( P =0.006 ). GN-037 demonstrated significant improvements in reducing erythema (57.6%, P =0.008) , plaque elevation (72.7%, P =0.001) , and scaling (80.3%, P =0.006) compared to placebo. 31.8% of patients in the GN-037 group achieved at least a 75% reduction in PASI , compared to 6.1% in the placebo group ( P =0.009 ). No new safety concerns emerged with similar treatment-emergent adverse events across all arms. Abidin Gülmüş , Chairman of GEN, stated: “We are thrilled to announce the positive results of our Phase 2 clinical trial. We believe GN-037 offers new hope for the global psoriasis community.” Nadir Ulu, MD, PhD , Vice President of R&D, added: “Our Phase 2 trial results highlighted GN-037’s potential to improve patient outcomes significantly, and it may provide a novel, well-tolerated treatment option for patients with mild to moderate plaque psoriasis.” About GEN: Founded in 1998, GEN is Türkiye’s leading speciality pharmaceutical company. It is focused on developing innovative therapies across multiple therapeutic areas, with significant R&D investments and a commitment to advancing global healthcare. GEN actively works in both in-licensing and out-licensing business models. GEN partners with leading global pharmaceutical companies to bring innovative therapies and rare solutions to communities in its countries. It also develops and produces highly demanded and competitive therapeutic products in its GMP-certified manufacturing facility to bring therapy solutions required in international markets. For more information, visit . For inquiries: Bulutay GÜNEŞ , Head of Corporate Brand, b.gunes@genilac.com Ali KETENCİOĞLU , Investor Relations Manager, a.ketencioglu@genilac.com Contact Information Bulutay Güneş Head of Corporate Brand b.gunes@genilac.com Ali Ketencioğlu Investor Relations Manager a.ketencioglu@genilac.com SOURCE: GEN Pharmaceuticals View the original press release on newswire.com.

临床结果临床2期

100 项与尿素/水杨酸/维A酸/丙酸氯倍他索相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
斑块状银屑病	临床2期	土耳其	Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS	2022-12-07
银屑病	临床1期	土耳其	Tc Erciyes University	2022-03-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05706870 (not provided, Pubmed \| Dermatol Ther (Heidelb))	临床2期	斑块状银屑病	190	GN-037 Cream	(衊觸廠願襯遞蓋醖齋顧) = 淵襯鬱構範網製鹹鹹窪簾觸觸鏇淵繭築廠顧鹹 (觸齋糧鑰膚鹹糧顧鏇遞 )	积极	2024-12-01
				Clobetasol 17-propionate (CP) Cream	(衊觸廠願襯遞蓋醖齋顧) = 憲鑰繭艱醖鑰鬱鏇糧夢簾觸觸鏇淵繭築廠顧鹹 (觸齋糧鑰膚鹹糧顧鏇遞 )
NCT05706870 (Biospace) 人工标引	临床2期	斑块状银屑病	190	GN-037 topical cream	(製壓構蓋糧糧壓築衊簾) = 餘淵鬱夢鬱膚憲願積窪淵製鏇窪壓膚襯範淵廠 (糧鏇鬱蓋醖膚窪糧顧鏇 ) 达到更多	积极	2024-09-25
				Placebo	(製壓構蓋糧糧壓築衊簾) = 願顧衊網構壓簾齋鹽壓淵製鏇窪壓膚襯範淵廠 (糧鏇鬱蓋醖膚窪糧顧鏇 ) 达到更多