BALLERUP, Denmark--(

巴勒鲁普，丹麦--(

BUSINESS WIRE

商业热线

)--

)--

NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

不适用于英国-不适用于英国媒体

LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results of the DELTA TEEN trial. DELTA TEEN is a pivotal phase 3 clinical trial with Anzupgo

LEO Pharma A/S是一家全球皮肤科医学领导者，今天宣布了DELTA TEEN试验的积极结果。DELTA TEEN是Anzupgo的关键3期临床试验

®

®

(delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of adolescents (aged 12-17) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.

（delgocitinib）20mg/g乳膏，一种局部泛Janus激酶（JAK）抑制剂，用于治疗青少年（12-17岁）中度至重度慢性手部湿疹（CHE），局部皮质类固醇不足或不合适。

1

1

This is the fifth phase 3 Anzupgo trial to achieve primary and all key secondary endpoints, validating the results of the previous clinical trials from the DELTA program.

这是第五项Anzupgo第三阶段试验，旨在实现主要和所有关键的次要终点，验证了DELTA计划先前临床试验的结果。

1,3-10

1,3-10

DELTA TEEN expands LEO Pharma’s growing portfolio of scientific evidence for the treatment of moderate to severe CHE, offering insight into a new patient population.

DELTA TEEN扩大了LEO Pharma不断增长的中重度CHE治疗科学证据组合，为新的患者群体提供了见识。

Currently, no treatment options are approved specifically for moderate to severe CHE in the adolescent population.

目前，尚未批准专门针对青少年人群中中度至重度CHE的治疗方案。

'

'

Research on adolescents with CHE has revealed that the condition can considerably affect their quality of life, including psychosocial well-being, school performance and leisure activities,'

对患有CHE的青少年的研究表明，这种情况会极大地影响他们的生活质量，包括心理社会健康、学校表现和休闲活动

said Professor Sonja Molin, Academic Dermatologist at Charite Universitätsmedizin Berlin and Adjunct Associate Professor of Dermatology at Queen’s University and coordinating investigator.

柏林查理特大学（Charite Universitätsmedizin Berlin）学术皮肤科医生、女王大学（Queen's University）皮肤病学副教授兼协调研究员Sonja Molin教授表示。

'

'

These findings further our understanding of how moderate to severe CHE manifests in adolescents and how to support this underserved patient group.'

这些发现进一步加深了我们对中度至重度CHE在青少年中的表现以及如何支持这一服务不足的患者群体的理解。”

The trial met the primary endpoint with a statistically significant improvement in CHE symptoms after 16 weeks of treatment with Anzupgo compared to cream vehicle.

与乳膏载体相比，用Anzupgo治疗16周后，该试验达到了主要终点，CHE症状有统计学显着改善。

1

1

Furthermore, the safety profile of Anzupgo was consistent with previous pivotal trials.

此外，Anzupgo的安全性与之前的关键试验一致。

1

1

“

“

The positive results from DELTA TEEN are encouraging and in line with LEO Pharma’s purpose of serving more and more people living with this debilitating condition,”

DELTA TEEN的积极成果令人鼓舞，符合LEO Pharma为越来越多患有这种衰弱疾病的人提供服务的宗旨。”

said Christophe Bourdon, Chief Executive Officer, LEO Pharma

利奥制药首席执行官克里斯托夫·波登说

. “

. “

Anzupgo is already available to adults in some markets, including Germany, and it is a critical next step to address the unmet need in this younger patient population.”

Anzupgo已经在包括德国在内的一些市场向成年人开放，这是解决这一年轻患者群体未满足需求的关键下一步。”

Currently, Anzupgo is approved for adults in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States..

。。

Detailed results from DELTA TEEN are planned to be submitted for scientific presentation and publication at a later date.

DELTA TEEN的详细结果计划稍后提交科学演示和出版。

For more information on the DELTA TEEN trial (NCT05355818) go to

有关DELTA青少年审判（NCT05355818）的更多信息，请访问

clinicaltrials.gov

clinicaltrials.gov 网站

.

.

Notes to editors

编辑注意事项

About Anzupgo

关于Anzupgo

®

®

(delgocitinib) cream

（Delgocitinib）奶油

Anzupgo is currently approved in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo is under investigation in other markets, including the United States..

目前，欧盟、英国、瑞士和阿拉伯联合酋长国已批准Anzupgo用于治疗局部皮质类固醇不足或不合适的成年人的中度至重度慢性手部湿疹（CHE）。Anzupgo正在包括美国在内的其他市场接受调查。。

Anzupgo

安祖普戈

®

®

(delgocitinib) cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.

（delgocitinib）乳膏是一种局部泛Janus激酶（JAK）抑制剂，用于治疗中度至重度CHE。它抑制JAK-STAT信号的激活，JAK-STAT信号在CHE的发病机制中起关键作用。

11

11

The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.

病理生理学的特征是皮肤屏障功能障碍，皮肤炎症和皮肤微生物组的改变。

12

12

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

2014年，LEO Pharma A/S和日本烟草公司（JT）签订了一项许可协议，LEO Pharma获得了独家开发和商业化delgocitinib乳膏的权利，用于全球皮肤科适应症的局部使用，日本除外，JT保留权利。

About the DELTA TEEN Trial

关于DELTA青少年审判

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of Anzupgo compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE.

DELTA TEEN是一项为期16周的3期随机，双盲，媒介物对照，平行组，多地点试验，旨在评估每日两次使用Anzupgo与乳膏载体相比在12-17岁青少年中的疗效和安全性中度至重度CHE。

1

1

The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.

DELTA TEEN的主要终点是研究者在第16周对慢性手部湿疹治疗成功率（IGA-CHE TS）的全球评估。治疗成功被定义为IGA-CHE评分为0（清晰）或1（几乎清晰），与基线相比至少有两步改善。

1

1

About Chronic Hand Eczema

关于慢性手部湿疹

Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.

慢性手部湿疹（CHE）被定义为持续三个月以上或一年内复发两次或两次以上的手部湿疹（HE）。

13,14

13,14

HE is the most common skin disorder of the hands

他是手部最常见的皮肤病

15

15

with a prevalence rate of approximately 4.7%.

患病率约为4.7%。

16

16

In a substantial number of patients, HE can develop into a chronic condition.

在大量患者中，他可能会发展为慢性病。

15

15

CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.

CHE是一种以瘙痒和疼痛为特征的波动性疾病，患者可能会出现红斑，鳞屑，苔藓化，角化过度，水泡，水肿以及手和手腕上的裂缝等体征。

17

17

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,

CHE已被证明会造成心理和功能负担，影响患者的生活质量，

18

18

with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.

大约70%患有严重CHE的人承认在日常活动中存在问题，并且由于这种情况而在日常生活中受到干扰。

19

19

Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.

。

20

20

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually.

利奥制药（LEO Pharma）是一家全球性公司，致力于通过创新提高护理标准，造福皮肤病患者。利奥制药由大股东利奥基金会（LEO Foundation）和北欧资本（Nordic Capital）于2021年共同拥有。利奥制药提供广泛的治疗组合，每年为1亿患者提供服务。

Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of EUR 1.5 billion..

利奥制药（LEO Pharma）总部位于丹麦，拥有4000人的全球团队。2023年，该公司净销售额为15亿欧元。。

References

参考文献

ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818.

ClinicalTrials.gov。国家医学图书馆（美国）。Delgocitinib乳膏对12-17岁青少年中度至重度慢性手部湿疹（DELTA TEEN）的疗效和安全性。标识符：NCT05355818。

https://clinicaltrials.gov/study/NCT05355818

https://clinicaltrials.gov/study/NCT05355818

.

.

Haft MA, Park HH, Lee SS, Sprague JM, Eichenfield LF. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173.

Haft MA，Park HH，Lee SS，Sprague JM，Eichenfield LF。小儿慢性手部湿疹：流行病学，临床表现和管理。JAAD Int.2023；11： 165年至173年。

ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711.

ClinicalTrials.gov。国家医学图书馆（美国）。Delgocitinib乳膏治疗成人中重度慢性手部湿疹（DELTA 1）的疗效和安全性。标识符：NCT04871711。

https://clinicaltrials.gov/ct2/show/NCT04871711

https://clinicaltrials.gov/ct2/show/NCT04871711

.

.

ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101.

ClinicalTrials.gov。国家医学图书馆（美国）。Delgocitinib乳膏治疗成人中重度慢性手部湿疹（DELTA 2）的疗效和安全性。标识符：NCT04872101。

https://clinicaltrials.gov/ct2/show/NCT04872101

https://clinicaltrials.gov/ct2/show/NCT04872101

.

.

ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA 3). Identifier: NCT04949841

ClinicalTrials.gov。国家医学图书馆（美国）。在完成DELTA 1或DELTA 2试验（DELTA 3）的受试者中进行开放标签多站点扩展试验。标识符：NCT04949841

https://clinicaltrials.gov/ct2/show/NCT04949841

https://clinicaltrials.gov/ct2/show/NCT04949841

.

.

Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4..

Bissonnette R，Warren RB，Pinter A等。delgocitinib乳膏治疗成人中度至重度慢性手部湿疹（DELTA 1和DELTA 2）的疗效和安全性：多中心，随机，对照，双盲，3期试验的结果。柳叶刀。2024年；404（10451）：461-473。doi:10.1016/S0140-6736（24）01027-4。。

Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0395..

Schliemann S等人。delgocitinib乳膏治疗成人中重度慢性手部湿疹的疗效和安全性：3期DELTA 2试验的结果。在2023年欧洲皮肤性病学会（EADV）大会上发表。德国柏林。10月11日至14日。海报展示#P0395。。

Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: results of the Phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0369..

Bissonnette R等人。delgocitinib乳膏治疗成人中度至重度慢性手部湿疹的疗效和安全性：3期DELTA 1试验的结果。在2023年欧洲皮肤性病学会（EADV）大会上发表。德国柏林。10月11日至14日。海报展示#P0369。。

ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722.

ClinicalTrials.gov。国家医学图书馆（美国）。一项为期24周的试验，比较了患有严重慢性手部湿疹的成年参与者每天两次服用20 mg/g Delgocitinib乳膏和每天一次的阿利维A酸胶囊的疗效和安全性。标识符：NCT05259722。

https://clinicaltrials.gov/study/NCT05259722

https://clinicaltrials.gov/study/NCT05259722

.

.

Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: 24-week Phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands.

Giménez-Arnau AM，Pinter A，Sondermann W等人。DELTA FORCE试验：24周3期试验，比较局部用delgocitinib乳膏与口服阿利维A酸胶囊对严重CHE成人的疗效和安全性。在2024年欧洲皮肤性病学会（EADV）大会上发表。荷兰阿姆斯特丹。

25-28 September. Late Breaking News Session. D1T01.

9月25日至28日。最新突发新闻。D1T01。

Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.

Dubin C，Del Duca E，Guttman Yassky E.治疗慢性手部湿疹的药物：成功和关键挑战。临床风险管理。2020年；16： 1319-1332年。勘误表：临床风险管理。2021年3月18日；17： 233页。

Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.

Lee GR，Maarouf M，Hendricks AK，Lee DE，Shi VY。手部湿疹的当前和新兴疗法。。2019年；32（3）：e12840。

Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.

。J Dtsch皮肤病杂志。2015年；13（1）：e1-e22。

Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.

Lynde C，Guenther L，Diepgen TL等。加拿大手部皮炎管理指南。J Cutan Med Surg。2010；14（6）：267-284。勘误表：J Cutan Med Surg。2011年11月至12月；15（6）：360。

Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.

Bissonnette R，Diepgen TL，Elsner P等。重新定义慢性手部湿疹（CHE）的治疗选择。J Eur Acad Dermatol Venereol。2010年；24补充3:1-20。

Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3..

Apfelbacher C，Bewley A，Molin S等。成人慢性手部湿疹的患病率：一项针对60000名普通人群的横断面多国研究。在2024年欧洲接触性皮炎学会（ESCD）大会上发表；2024年9月4日至7日；德国德累斯顿。海报展示#3。。

Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.

Thyssen JP，Schuttelaar MLA，Alfonso JH等。手部湿疹的诊断、预防和治疗指南。。2022年；86（5）：357-378。

Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.

Grant L，Seiding Larsen L，Burrows K等。基于对患者和专家皮肤科医生的定性访谈，开发慢性手部湿疹（CHE）的概念模型。高级Ther。2020年；37（2）：692-706。

Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.

Cortesi PA，Scalone L，Belisari A等。局部强效皮质类固醇标准治疗难治的严重慢性手部湿疹患者的成本和生活质量。。2014年；70（3）：158-168。

Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.

沃伯格·安（Voorberg AN），洛曼·L（Loman L），舒特拉尔（Schuttelaar MLA）。荷兰普通人群手部湿疹的患病率和严重程度：生命线队列研究中的横断面问卷研究。性病学报。2022年；102:adv00626。

MAT-79328 February 2025

MAT-79328 2025年2月