BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the positive outcome of the DELTA 3 trial. DELTA 3 is a phase 3, single-arm, open-label extension trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE)..

丹麦BALLERUP-（BUSINESS WIRE）-医学皮肤病学全球领导者LEO Pharma A/S今天宣布了DELTA 3试验的积极成果。DELTA 3是一项研究性局部泛Janus激酶（JAK）抑制剂delgocitinib霜的3期单臂开放标签扩展试验，用于治疗中度至重度慢性手部湿疹（CHE）成人。。

In the DELTA 3 trial, the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE was evaluated.1 The results showed that the long-term safety profile remained consistent with previous results from the DELTA 1 and 2 trials.

在DELTA 3试验中，评估了中度至重度CHE成人每天两次根据需要用delgocitinib乳膏治疗长达36周的长期安全性.1结果显示长期安全性保持一致以前的结果来自DELTA 1和2试验。

Delgocitinib cream was generally well tolerated over the 36-week period..

Delgocitinib乳膏在36周内通常具有良好的耐受性。。

All DELTA 3 trial subjects had completed the DELTA 1 or DELTA 2 trials and were offered to immediately enroll into this extension trial. This included patients treated with delgocitinib cream for the initial 16-week treatment period, as well as the patients who received cream vehicle.1

所有DELTA 3试验受试者均已完成DELTA 1或DELTA 2试验，并被提供立即参加该延长试验。这包括在最初的16周治疗期间用delgocitinib乳膏治疗的患者，以及接受乳膏载体治疗的患者

Patients who entered the DELTA 3 trial after 16 weeks of twice-daily treatment with delgocitinib cream in the DELTA 1 and 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.

在DELTA 1和2试验中使用delgocitinib霜每日两次治疗16周后进入DELTA 3试验的患者在另外的36周治疗方案中保持相似水平的症状缓解和治疗成功。

Furthermore, patients who entered the DELTA 3 trial after receiving cream vehicle in the DELTA 1 and DELTA 2 trials reached similar levels of treatment success as the patients previously treated with delgocitinib cream.

此外，在DELTA 1和DELTA 2试验中接受乳膏载体后进入DELTA 3试验的患者达到与先前用delgocitinib乳膏治疗的患者相似的治疗成功水平。

'It is encouraging to see the level of consistency that these long-term results show, in line with the previous positive results from the pivotal DELTA 1 and 2 trials. This condition can have a negative impact on patient quality of life, physical functioning, and ability to work, and there are currently no topical treatments specifically approved for moderate to severe chronic hand eczema,' said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.

“令人鼓舞的是，这些长期结果显示的一致性水平与之前关键的DELTA 1和2试验的积极结果一致。这种情况可能会对患者的生活质量，身体机能和工作能力产生负面影响，目前还没有专门针对中度至重度慢性手部湿疹批准的局部治疗，“利奥首席开发官Kreesten Meldgaard Madsen说制药。

'We will continue our work to investigate delgocitinib cream as a potential topical treatment for patients affected by this hard-to-treat disease.”.

“我们将继续努力研究delgocitinib乳膏作为受这种难治性疾病影响的患者的潜在局部治疗方法。”。

Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 3 are planned to be submitted for scientific presentation and publication at a later date.

将对数据集进行进一步分析以确定delgocitinib霜在治疗中度至重度CHE的成人中的全部潜力。DELTA 3的详细结果计划在晚些时候提交给科学介绍和出版。

For more information on the DELTA 3 trial (NCT04949841) go to clinicaltrials.gov.

有关DELTA 3试验（NCT04949841）的更多信息，请访问clinicaltrials.gov。

About the DELTA 1, 2 and 3 Trials

关于三角洲1,2和3试验

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE.2,3.

随机，双盲，载体对照，多中心3期临床试验（DELTA 1和DELTA 2）的主要目的是评估每日两次应用delgocitinib乳膏与乳膏载体治疗成人的疗效。中度至重度CHE.2,3。

The primary endpoint of the DELTA 1 and DELTA 2 trials 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. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe)..

DELTA 1和DELTA 2试验的主要终点是研究者在第16周对慢性手部湿疹治疗成功（IGA-CHE TS）的全面评估。治疗成功定义为IGA-CHE评分为0（清除）或1（几乎清除），与基线相比至少有两步改善。其他IGA-CHE评分包括2（轻度），3（中度）和4（严重）。。

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.

第16周的关键次要终点包括从基线至第16周通过手部湿疹症状日记（HESD）测量的≥4分的瘙痒和疼痛评分的减少，以及从基线至少75%的改善和至少90%的改善从第16周手部湿疹严重程度指数（HECSI）的基线开始。

The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials..

从基线到第16周的治疗紧急不良事件的数量确定了试验的关键安全终点。。

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to enroll into the DELTA 3 extension trial. The purpose of this extension trial was to evaluate the long-term safety of twice-daily as needed treatment with delgocitinib cream.

在试验DELTA 1或DELTA 2中每天两次用delgocitinib乳膏或乳膏载体完成16周治疗的受试者被提供参加DELTA 3延长试验。该延长试验的目的是评估每天两次根据需要用delgocitinib霜治疗的长期安全性。

Subjects visited the clinic every 4 weeks to assess the safety and efficacy of the treatment, as well as its effect on patient-reported outcomes (PROs) until Week 36, with a final follow-up phone call planned on Week 38.1.

受试者每4周访问一次诊所，以评估治疗的安全性和有效性，以及其对患者报告结果（PRO）的影响，直至第36周，计划在第38.1周进行最终随访电话。

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.4,5 HE is the most common skin disorder of the hands6 with a one-year prevalence rate of approximately 9%.7 In a substantial number of patients, HE can develop into a chronic disease.6 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.8.

慢性手部湿疹（CHE）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）.4,5 HE是手部最常见的皮肤病6，患病率为一年。大约9%.7在大量患者中，他可以发展成慢性疾病.6 CHE是一种以瘙痒和疼痛为特征的波动性疾病，患者可能会出现手部和腕部红斑，鳞屑，苔藓化，角化过度，囊泡，水肿和裂隙等症状。

About delgocitinib

德尔戈西替尼

Delgocitinib cream is an investigational, first-in-class, topical pan-Janus kinase (JAK) inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.9 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.10 LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults, which is currently not approved by any health authority.

Delgocitinib乳膏是一种用于CHE的研究性一流局部泛Janus激酶（JAK）抑制剂。它抑制JAK-STAT信号传导的激活，JAK-STAT信号传导在CHE的发病机制中起关键作用.9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.10 LEO Pharma目前正在开发delgocitinib用于治疗成人中度至重度慢性手部湿疹（CHE）的乳膏制剂，目前尚未得到任何卫生部门的批准。

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 for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights..

2014年，LEO Pharma A/S和Japan Tobacco Inc.（JT）签订了许可协议，LEO Pharma获得开发和商业化delgocitinib的专有权利，用于全球皮肤病适应症的局部使用，不包括日本，其中JT保留权利。。

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

LEO Pharma是一家全球性公司，致力于提高护理标准，为皮肤病患者，家属和社会带来利益。LEO Pharma成立于1908年，多数由LEO基金会所有，致力于数十年的研究和开发以推进皮肤病学科学，如今，该公司为所有疾病严重程度提供广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion..

LEO Pharma总部设在丹麦，拥有4700人的全球团队，为全球数百万患者提供服务。2022年，该公司净销售额为106亿丹麦克朗。。

References

工具书类

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. https://clinicaltrials.gov/study/NCT04949841.

ClinicalTrials.gov。国家医学图书馆（美国）。完成DELTA 1或DELTA 2试验（DELTA 3）的受试者的开放标签多位点延伸试验。标识符：NCT04949841。https://clinicaltrials.gov/study/NCT04949841.

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. https://clinicaltrials.gov/study/NCT04871711.

ClinicalTrials.gov。国家医学图书馆（U.S.）。Delgocitinib乳膏在中重度慢性手部湿疹（DELTA 1）成人中的疗效和安全性。标识符：NCT04871711。https://clinicaltrials.gov/study/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. https://clinicaltrials.gov/ct2/show/NCT04872101.

ClinicalTrials.gov。国家医学图书馆（U.S.）。Delgocitinib乳膏在中重度慢性手部湿疹（DELTA 2）成人中的疗效和安全性。标识符：NCT04872101。https://clinicaltrials.gov/ct2/show/NCT04872101.

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MAT-69414 October 2023

MAT-69414 2023年10月