Phase III Clinical Study of JTE-052 new drug product - Bioequivalence study between new drug product and JTE-052 ointment in patients with atopic dermatitis -

开始日期2024-04-22

申办/合作机构-

JPRN-jRCT2031230570

/ Completed临床1期IIT

Phase I Clinical Study of JTE-052 new drug product - Dermal Safety Study -

开始日期2024-02-19

申办/合作机构-

100 项与德戈替尼相关的临床结果

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100 项与德戈替尼相关的转化医学

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100 项与德戈替尼相关的专利（医药）

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121

项与德戈替尼相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Topical delgocitinib for the treatment of chronic hand eczema

Review

作者: Yilmaz, Orhan ; Torres, Tiago ; Elshaikh Berair, Mohamed ; Abdelhalim, Asaad

PURPOSE:

Chronic hand eczema (CHE) is a prevalent dermatological condition characterized by significant morbidity and impaired quality of life. Delgocitinib, a pan-JAK inhibitor, has emerged as a promising topical treatment for CHE, targeting key cytokine-mediated inflammatory pathways involved in the disease. Delgocitinib 20 mg/g (2%) cream was approved by the European Medicines Agency (EMA) in 2024 for moderate-to-severe CHE, and its U.S. Food and Drug Administration (FDA) review is currently in progress.

MATERIALS AND METHODS:

PubMed, Medline and ClinicalTrials.gov were searched up to January 21, 2025, using specific search terms related to delgocitinib and chronic hand eczema.

RESULTS AND CONCLUSIONS:

Clinical trials have demonstrated its effectiveness in improving disease severity, including eczema signs and symptoms such as pain and itching, and enhancing patient-reported outcomes compared to vehicle. Topical delgocitinib has shown a favorable safety profile, with most adverse events being mild and unrelated to treatment. Serious adverse events were rare, and treatment discontinuation due to adverse events was minimal. This narrative review synthesizes current evidence on topical delgocitinib's clinical utility and safety in CHE, positioning it as a valuable therapeutic option. Further comparative studies are needed to evaluate its efficacy against oral JAK inhibitors and other topical immunosuppressants, providing insight into optimizing treatment strategies for this chronic condition.

2025-05-12·Skin health and disease

A case of refractory alopecia areata successfully treated by combining delgocitinib ointment with excimer laser

Article

作者: Kogame, Toshiaki ; Kambe, Naotomo ; Kakeji, Yukito ; Kabashima, Kenji ; Yagi, Yosuke

Abstract:

Alopecia areata (AA) is an autoimmune disease that causes recurrent hair loss. No treatment has been effective in the long term because of the unstable efficacy and possible side effects. AA is primarily driven by Th1-type inflammation, centred around CD8+ T cells and interferon-γ (IFN-γ). Recent studies have revealed that the Janus kinase (JAK) family is also involved in the pathogenesis of AA, leading to JAK inhibitors emerging as a treatment for AA. We present a case of a 39-year-old Japanese woman with severe AA who exhibited a Severity of Alopecia Tool (SALT) score 80 accompanied by atopic dermatitis (AD). Despite conventional treatments, the condition worsened from a SALT score of 80 to 100. We subsequently attempted treatment with an excimer laser (EL), but no hair regrowth was observed. However, the introduction of 0.5% delgocitinib ointment in combination with EL led to complete hair regrowth beginning 2 months later, with complete remission achieved after 1 year. This case highlights the potential efficacy of combining delgocitinib ointment with EL in treating severe AA, particularly in patients with AD. The findings suggest that this combination therapy may provide a safer and more effective alternative to oral JAK inhibitors. Nevertheless, further studies are needed to elucidate the underlying mechanisms and fully evaluate the therapeutic synergy.

2025-05-01·Dermatology and Therapy

Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream

Article

作者: Agner, Tove ; Thyssen, Jacob P ; Apol, Eydna D ; Bauer, Andrea ; Hagen, Berith Fredsted ; Ehst, Benjamin D ; Hahn-Pedersen, Julie ; Buhl, Timo

INTRODUCTION:

Chronic Hand Eczema (CHE) is a multifactorial, burdensome, inflammatory skin disease, with limited treatment options. In a double-blind dose-ranging phase 2b clinical trial, participants with CHE received delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, or cream vehicle (clinical results published elsewhere). The objectives were to analyse patient-reported outcomes (PROs) in participants with mild and moderate to severe CHE at screening, and to investigate the impact on PROs during treatment in participants with moderate to severe CHE.

METHODS:

Firstly, Dermatology Life Quality Index (DLQI), EQ-5D-5L, and Hand Eczema Impact Scale (HEIS) per severity were analysed at screening. Secondly, PROs were analysed in the subset of participants with moderate to severe CHE; participants receiving delgocitinib cream 20 mg/g were compared with participants receiving cream vehicle for 16 weeks.

RESULTS:

At screening, mean (SD) DLQI, EQ-5D-5L, and HEIS were 8.1 (5.8), 0.788 (0.175), and 1.7 (0.8), respectively for mild CHE (n = 93), and 12.1 (6.9), 0.689 (0.236), and 2.3 (0.9) for participants with moderate to severe CHE (n = 202), respectively. Among the participants with moderate to severe CHE who received delgocitinib (n = 41), the least squares mean [SE] change from baseline to week 16 improved compared to cream vehicle (n = 38) in DLQI (- 7.1 [0.9] vs. - 4.6 [0.9]), EQ-5D-5L (0.228 [0.032] vs. 0.096 [0.034]), and HEIS (- 1.5 [0.2] vs. - 0.8 [0.2]) (P < 0.05).

CONCLUSIONS:

Mild CHE had a moderate effect, whereas moderate to severe CHE had a very large effect on patients' Health-Related Quality of Life at screening. Treatment with delgocitinib cream was associated with considerable improvement in PROs and represents a potentially valuable treatment option.

TRIAL REGISTRATION:

ClinicalTrials. gov identifier NCT03683719.

项与德戈替尼相关的新闻（医药）

2025-05-15

·Business Wire

Three-month interim report (Q1) 2025 (Unaudited): LEO Pharma Delivers 9% Revenue Growth at Constant Exchange Rates and Doubles Adjusted EBITDA Margin to 16%

BALLERUP, Denmark--(BUSINESS WIRE)--In Q1, LEO Pharma continued its robust growth, driven by dermatology, and made significant strategic progress. This included expanding the launch of Anzupgo® to five markets, advancing innovation through the newly formed strategic partnership with Gilead for the STAT6 program, and significantly improving profitability with a return to a positive net profit. Q1 2025 highlights LEO Pharma’s revenue increased by 10% year-on-year to DKK 3,373 million, and by 9% at constant exchange rates (CER). The revenue growth was led by North America (+45% at CER), with Europe (+2% at CER) and Rest of World (+5% at CER) also contributing to the overall growth. Dermatology portfolio revenue grew by 10% (CER) year-on-year, driven by the Strategic brands, Adtralza®/Adbry® and Anzupgo®, which together saw a revenue increase of 73% (CER). Sales in the Thrombosis portfolio declined by 1% (CER) year-on-year, negatively impacted by order timing. Operating profit improved significantly, with adjusted EBITDA reaching DKK 545 million in Q1 2025, reflecting a margin of 16% (Q1 2024: 8%) excluding the upfront payment from Gilead and other non-recurring items. Net profit for the quarter was DKK 1,742 million (Q1 2024: negative DKK 366 million), including non-recurring items. Free cash flow was positive DKK 1,386 million for Q1 2025 (Q1 2024: negative DKK 571 million), and net interest-bearing debt was reduced to DKK 9,750 million (YE 2024: DKK 11,115 million). Excluding one off M&A-related payments, free cash flow in Q1 2025 was negative DKK 241 million. In Q1, LEO Pharma reported positive results from the DELTA TEEN and DELTA China trials, marking the fifth and sixth consecutive successful phase 3 trials for delgocitinib (brand name: Anzupgo®) in chronic hand ezcema. Additionally, in January, LEO Pharma announced a strategic partnership with Gilead Sciences to accelerate the pre-clinical STAT6 program. The 2025 financial outlook for revenue growth of 6-9% (CER) and an adjusted EBITDA margin of 15-18% is unchanged and confirmed. "We have seen a good start to 2025, with encouraging progress in the ongoing launch of Anzupgo® and key milestones achieved for our innovation pipeline. A significant highlight is the acceleration of the STAT6 program through our new partnership with Gilead. Additionally, the return to a positive net result marks another key milestone for the quarter, as we continue to develop the foundations for LEO Pharma’s long-term financial strength,” says Christophe Bourdon, CEO of LEO Pharma. Q1 2025 Financial overview (DKK million) Q1 2025 Q1 2024 Growth as reported Revenue 3,373 3,064 10% Revenue growth at CER 9% 13% N.m. Adjusted EBITDA 545 257 112% Net profit /(loss) for the period 1,742 (366) N.m. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com

财报临床结果临床3期

2025-05-11

·精准药物

JAK激酶及其抑制剂

JAK/STAT 轴与癌症、炎症和免疫有关。许多细胞因子/生长因子影响 JAK/STAT 信号传导。JAK家族成员的种系突变和多态性均与特定疾病相关：系统性红斑狼疮；严重联合免疫缺陷；小儿急性淋巴细胞白血病；和遗传性血小板增多症。本文总结了JAK 信号通路与临床的相关性，及JAK抑制剂的临床应用。 1. 背景介绍Janus 激酶(JAK) 是细胞内非受体酪氨酸激酶家族，可通过 JAK-STAT 途径转导细胞因子介导的信号。Janus 这个名字源自前后双面的罗马神，因为 JAK 拥有两个相似的磷酸盐转移结构域，其中一个显示激酶酶活性，而另一个基序在反馈环路中负调节第一个基序的激酶活性。JAK-STAT 信号传导由三种主要蛋白质组成：细胞表面受体、JAK 和 STAT。JAK 发挥酪氨酸激酶的作用，与 I 型和 II 型细胞因子受体的细胞质区域结合。一旦配体与受体结合，JAK 就会向受体添加磷酸盐。然后两个 STAT 蛋白与磷酸盐结合并形成二聚体。二聚体进入细胞核，与 DNA 结合，随后靶基因转录。总体而言，JAK-STAT 通路对于癌细胞的增殖和存活至关重要，并可能导致耐药性。JAK-STAT 通路由 50 多种不同的前细胞因子受体激活，这些受体通过信号通路控制造血、免疫反应、胚胎发生和炎症。该途径在多种免疫介导的疾病和恶性过程的发病机制中具有重要作用。JAK 抑制剂是一类通过 JAK-STAT 通路阻断信号传导的药物。JAK 抑制剂（也称为 jakinibs）通过阻止JAK蛋白磷酸化发挥作用，从而减弱细胞内信号传导。JAK 抑制剂最广泛的临床研究是在类风湿性关节炎 (RA) 和骨髓纤维化疾病，但 JAK 抑制剂也已应用于皮肤科，用于治疗银屑病/银屑病关节炎、特应性皮炎、斑秃、白癜风和皮肌炎等疾病。2. JAK 的结构和功能JAK-STAT 通路的主要功能是将信号从细胞膜上的受体（可分为 IL 受体、IFN 受体或CSFR受体）传递到细胞核。该途径对于细胞因子和生长因子功能是必需的，导致重要的细胞过程，例如骨髓和淋巴分化/增殖/造血、哺乳、免疫系统发育和促炎反应。图 1. JAK1、JAK2、JAK3、TYK2/STAT 通路的功能作用：JAK 家族和 TYK 蛋白的多个成员参与 JAK/STAT 通路。作用包括增强调节反应和免疫系统调节、骨髓和淋巴分化/增殖以及促炎症反应。细胞因子是分泌的糖蛋白，作为细胞间信使，刺激靶细胞的分化、增殖和程序性细胞死亡。它们通过与靶细胞表面的特定受体结合并开启由激酶启动的基于磷酸酪氨酸的细胞内信号级联，然后由包含 SH2 结构域的转录因子传播来发挥作用。由于细胞因子信号传导是增殖性的并且通常是炎症性的，因此其幅度和持续时间受到严格控制。大多数细胞因子是小螺旋蛋白，长度通常为 150-200 个氨基酸。根据其受体中识别的元素，它们分为两类。I 类细胞因子由四个 α 螺旋组成，呈上-上-下-下构型。其中，例如 IL5，以二聚体形式存在，但拓扑结构是保守的。上-上-下-下构象需要两个长环来连接上-上和下-下对。在 II 类细胞因子中，这些环中的一个或两个被额外的 α 螺旋取代，从而产生以反平行方式排列的五到六个螺旋。通过 JAK-STAT 的 I 类细胞因子信号传导包括但不限于 IL2、IL3 家族、IL4、IL6 家族、IL7、IL9、IL12、IL13、IL15、IL21、IL23、G-CSF、GM-CSF、EPO、TPO。II类细胞因子包括但不限于IFN-α、-β、-ε、-κ、-omega、-γ、IL10、IL19、IL20、IL22、IL24、IL26。细胞因子信号级联仅需要三个元件（受体、激酶和转录因子）即可引发反应。每种细胞因子与其靶细胞表面的特定受体结合。这些受体含有与酪氨酸激酶JAK家族成员组成型相关的细胞内基序。JAK 家族的四个成员是：JAK1、JAK2、JAK3 和酪氨酸激酶 2 (TYK2)。JAK 在细胞因子暴露前处于失活状态。然而，一旦细胞因子与其受体结合，它就会通过转磷酸化诱导其自动激活。一旦被激活，JAK 就会磷酸化特定酪氨酸上受体的细胞内尾部，从而充当转录因子 STAT 家族成员的对接位点。STAT 家族由七个成员 STAT1、STAT2、STAT3、STAT4、STAT5a、STAT5b 和 STAT6 组成，如上所述，它们主要充当转录因子。然后，受体定位的 STAT 被 JAK 磷酸化，导致它们与受体解离并易位到细胞核，在细胞核中驱动细胞因子反应基因的表达。为了确保信号传导正确关闭，许多蛋白质在途径的多个水平上抑制细胞因子信号传导。重要的是，细胞因子信号传导抑制因子（SOCS）家族是信号传导级联的负反馈抑制剂。细胞因子信号转导的一般规则是，每种细胞因子与特定受体结合，促进特定 JAK 和 STAT 的激活，并且信号转导由特定 SOCS 蛋白关闭。3. JAK 遗传突变与疾病JAK 家族成员 – JAK1、JAK2、JAK3 和 TYK 2 – 与细胞生长、存活和发育有关，并且对于多种细胞（包括免疫细胞和造血元件）的分化至关重要。因此，这些基因的遗传突变或特定多态性与疾病相关也就不足为奇了。JAK基因的激活和功能丧失体细胞改变都可能发生。激活JAK改变与大多数血液恶性肿瘤的发生有关。JAK2功能丧失改变与免疫检查点阻断抵抗相关。JAK-激活改变各种JAK基因的体细胞改变主要与各种血液系统恶性肿瘤相关。例如，获得性体细胞突变JAK2 V617F持续激活 JAK2 激酶，是骨髓增殖性疾病中最常见的分子事件。大约 95% 的真性红细胞增多症病例以及 55%–60% 的原发性血小板增多症和原发性骨髓纤维化病例中观察到这种情况。JAK2 V617F也存在于正常人群中。在哥本哈根普通人口研究的 49,488 名个体中，有 63 名 (0.1%) 的 JAK2V617F 突变检测呈阳性。其中，48 人最终被诊断患有骨髓增生性肿瘤。JAK家族突变也在患有多种 T 细胞恶性肿瘤的患者亚群中观察到，包括 T-ALL、T-PLL 和 Sezary 综合征，以及儿童 B 细胞前体 ALL 和急性巨核细胞白血病也存在激活的JAK1突变导致其酪氨酸激酶活性的组成性激活，已在 ALL 和非典型慢性粒细胞白血病中观察到。JAK功能丧失改变体细胞基因组拷贝数改变，涉及关键 IFNγ 基因功能诱导剂JAK2的丢失，是免疫抵抗和逃逸的关键驱动因素。晚期黑色素瘤和其他癌症患者对免疫检查点治疗（包括PD-1阻断）的获得性耐药分别与JAK2缺失和功能丧失突变相关。研究表明， JAK2和PD-LI （染色体 9p24 上发现的两个邻近基因）的缺失与复发性人乳头瘤病毒阴性头颈鳞状癌中抗PD-1免疫疗法的原发性耐药相关。并且 CAP/CLIA 经验证可在临床中使用，以在这种情况下选择最佳治疗。因此， JAK2介导的 IFNγ 反应性的缺乏使得癌细胞能够逃离抗肿瘤 T 细胞，并且在抗PD-1/L1免疫治疗的背景下，消除了这种方法的抗肿瘤功效。与这些PD-L1-JAK2共缺失抗性发现一致， JAK2 、 PD-L1 （和PDL2 ；9p24.1）扩增或 9p 拷贝数增益与相反的效果相关，即抗PD-1免疫治疗益处。PD-L1 表达增加可能由 9p24.1 扩增（或 9p 拷贝数增益）直接引起，也可能由 JAK2 信号传导增加间接引起，与针对 9p 扩增肿瘤的免疫治疗反应相关。这些结果可能适用于其他肿瘤/部位和治疗，特别是考虑到JAK2在癌细胞对 IFNγ 的敏感性、抗原呈递受损、T 细胞敏感性和逃避方面发挥着关键、广泛的作用。4. 临床中的 JAK 抑制剂大量的功能数据为阻断JAK作为新型免疫调节药物的激酶活性的抑制剂的产生提供了强大的动力。临床前疾病模型，包括关节炎、移植、移植物抗宿主病和其他自身免疫性疾病模型，并进入了临床试验。此外，在骨髓增殖性肿瘤（包括骨髓纤维化、真性红细胞增多症和原发性血小板增多症）中发现JAK2功能获得性突变，为临床开发JAK抑制剂（jakinibs）提供了额外的动力（下表）。表 .FDA 批准用于临床的 JAK 抑制剂。第一个获得批准的JAK抑制剂是 JAK1/JAK2 抑制剂鲁索替尼 (ruxolitinib) 。基于骨髓纤维化中功能获得性JAK2突变的鉴定，鲁索替尼于 2011 年被批准用于该适应症。随后，鲁索替尼也被批准用于治疗类固醇难治性急性移植物抗宿主病，以及治疗特应性皮炎的霜剂。近年，fedratinib（一种选择性JAK2抑制剂）也被批准用于治疗骨髓纤维化。tofacitinib 是一种 JAK1/JAK2/JAK3 抑制剂，被批准用于治疗 RA、银屑病关节炎、多关节型幼年特发性关节炎和溃疡性结肠炎。Baricitinib 是一种 JAK1/JAK2 抑制剂，被批准用于治疗 RA，最近又被批准用于治疗斑秃。它还在欧洲被批准用于治疗特应性皮炎。Upadacitinib 对 JAK1 比 JAK2 具有一定程度的选择性，并被批准用于治疗 RA、银屑病关节炎和特应性皮炎。Abrocitinb 也是一种选择性JAK1抑制剂，被批准用于治疗特应性皮炎。其他几种 JAK 抑制剂已在欧洲或日本被授权用于类似的适应症：filgotinib、peficitinib、delgocitinib 和 oclacitinib。正在进行的临床试验正在研究 jakinibs 在多种其他疾病中的疗效，例如斑秃、强直性脊柱炎、炎症性肠病、皮肌炎、间质性肺病、狼疮、血管炎、白癜风和重症肌无力。JAK 抑制剂的副作用是增加感染风险。上呼吸道、下呼吸道（包括肺结核）、尿路感染等常见感染的发病率较一般人群较高。此外，对于那些用于治疗慢性炎症的 JAK 抑制剂，FDA 要求警告其增加心脏事件、癌症和血栓的风险。5. JAK/STAT 通路的未来治疗干预方向JAK/STAT 通路的不同组成部分，例如受体、JAK、STAT基因家族、和基因转录因子与其他信号通路相互干扰。这些信号串扰在多能性、分化、免疫调节和肿瘤发生中发挥着非常重要的作用，这可能对未来的治疗发展很重要。此外，参与胚胎发育和细胞稳态的 TGFβ 信号通路成分与 JAK/STAT 通路成分相互作用，并且可以上调或下调该通路。SMAD 蛋白（TGFβ 通路的调节剂）和 STAT 蛋白通常共享相同的转录复合物。一个例子是由 p300 连接的 STAT3 和 SMAD1 复合物，它可诱导星形胶质细胞分化。TGFβ 信号通路受 Notch 通路调节，参与细胞增殖、分化和细胞死亡。Notch 通路的组成部分还与 JAK/STAT 通路相互作用，并已在果蝇的器官发育中进行了研究。Notch 通路通过干扰 STAT 核易位到 DNA 结构域来抑制 JAK/STAT 信号。例如，在果蝇中枢神经系统的发育过程中，Hes 蛋白（Notch 的下游效应子）促进 JAK2 磷酸化 STAT3。这些通路之间的串扰表明，未来在开发 JAK 通路抑制剂时，TGFβ 和 Notch 通路调节剂可能值得考虑。参考：10.1158/1535-7163.MCT-22-0323声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

2025-04-24

·Business Wire

LEO Pharma Announces Publication of Head-to-Head DELTA FORCE Study Results in The Lancet

TORONTO--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, is pleased to share that The Lancet, which is considered one of the most influential peer-reviewed medical journals in the world, has published an article discussing the findings of the DELTA FORCE trial for investigational delgocitinib cream. The publication summarizes the results of DELTA FORCE, a phase 3, two-arm trial (N=513) that compares the efficacy and safety of delgocitinib cream with alitretinoin capsules.1 Alitretinoin is the only treatment currently approved in Canada to treat severe CHE in patients who do not respond to topical corticosteroids.2 In Canada and the US, delgocitinib cream is currently under review and has not been approved by Health Canada or the FDA. Delgocitinib cream achieved the primary outcome measure of the DELTA FORCE trial, assessing the Hand Eczema Severity Index (HECSI) scores from baseline to Week 12 compared to alitretinoin capsules. Delgocitinib cream also met all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, a reduction in HECSI scores from baseline to Week 24, and improvement in health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI). Furthermore, patients receiving delgocitinib cream had fewer treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules. “The discussion of delgocitinib and the presentation of DELTA FORCE data in The Lancet is an exciting moment for the LEO Pharma team,” said Robert Spurr, EVP, LEO Pharma, North America and President, LEO Pharma, US. “We are proud to contribute to the overall understanding of moderate to severe chronic hand eczema, helping uncover potentially new treatment options for those living with skin conditions like CHE.” “We know that CHE is an under researched condition,” commented Dr. Charles Lynde, Chief Medical Director, The Lynde Institute for Dermatology & Lynderm Research Inc. and Associate Professor, University of Toronto, Department of Medicine. “We hope that discussions of the DELTA FORCE program, like that published in The Lancet, will continue to raise awareness of the disease, inspire new research, and ultimately help improve the quality of life of those living with CHE.” About The Lancet The Lancet is a world-leading source of clinical, public health, and global health knowledge. Lancet journals have an extensive global reach with more than 36.6 million annual visits and 108.1 million downloaded articles.3 About the DELTA FORCE Trial DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.1 The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.1 All 14 North American DELTA FORCE clinical trial sites were located in Canada.4 About Chronic Hand Eczema 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.5,6 HE is the most common skin disorder of the hands7 with a prevalence rate of approximately 4.7%.8 In a substantial number of patients, HE can develop into a chronic condition.7 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.2 CHE has been shown to cause psychological and functional burdens that impact patient quality of life,9 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.10 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.11 About delgocitinib cream 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.12 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.13 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. Delgocitinib cream is currently approved and marketed under the trade name Anzupgo® 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. Delgocitinib is under investigation in Canada and the United States. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com. LEO Pharma Canada is located in Toronto, Ontario. References: 1 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. https://classic.clinicaltrials.gov/ct2/show/NCT05259722. 2 Thyssen JP, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis 2022;86:357–378. 3 The Lancet. About The Lancet. Published: 2024. Last assessed: Jun 25, 2024. Available at: https://www.thelancet.com/lancet/about. 4 Giménez-Arnau, Ana Maria et al. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial The Lancet, April 16, 2025 Available at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00001-7/abstract 5 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. 6 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. 7 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. 8 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. 9 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. 10 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. 11 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. 12 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. 13 Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. MAT- 81870 April 2025

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适应症	国家/地区	公司	日期
慢性湿疹	欧盟	LEO Pharma A/S	2024-09-19
慢性湿疹	冰岛	LEO Pharma A/S	2024-09-19
慢性湿疹	列支敦士登	LEO Pharma A/S	2024-09-19
慢性湿疹	挪威	LEO Pharma A/S	2024-09-19
特应性皮炎	日本	Japan Tobacco, Inc.	2020-01-23

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适应症	最高研发状态	国家/地区	公司	日期
下颌面骨发育不全	临床3期	中国	LEO Pharma A/S	2023-09-05
下颌面骨发育不全	临床3期	中国	LEO Laboratories Ltd.	2023-09-05
下颌面骨发育不全	临床3期	中国	上海励奥医药咨询有限公司	2023-09-05
汗疱疹	临床3期	丹麦	LEO Pharma A/S	2022-01-30
汗疱疹	临床3期	丹麦	Japan Tobacco, Inc.	2022-01-30
前额纤维化脱发	临床2期	丹麦	Japan Tobacco, Inc.	2022-01-30
盘状红斑狼疮	临床2期	美国	Leo Pharma, Inc.	2019-07-09
盘状红斑狼疮	临床2期	丹麦	Leo Pharma, Inc.	2019-07-09
盘状红斑狼疮	临床2期	法国	Leo Pharma, Inc.	2019-07-09
盘状红斑狼疮	临床2期	德国	Leo Pharma, Inc.	2019-07-09

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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


NCT05259722 (DELTA FORCE, Pubmed) 人工标引	临床3期	慢性湿疹	513	delgocitinib cream	艱繭構窪範憲選窪積繭(淵範醖築範衊獵觸獵選) = 糧積淵憲餘簾襯積憲衊蓋積艱蓋襯遞鑰餘鬱醖 (選鹹齋選衊艱襯糧顧襯, 3.4) 更多	优效	2025-04-01
				alitretinoin	艱繭構窪範憲選窪積繭(淵範醖築範衊獵觸獵選) = 選餘鬱窪襯壓鹹廠窪顧蓋積艱蓋襯遞鑰餘鬱醖 (選鹹齋選衊艱襯糧顧襯, 3.4) 更多
NCT05259722 (DELTA FORCE, CTgov)	临床3期	慢性湿疹	513	Delgocitinib (Delgocitinib Cream 20 mg/g)	膚膚鏇獵鏇蓋製鏇範簾(鬱齋鑰網範獵蓋製鑰鬱) = 廠願蓋網繭餘築觸憲餘鏇糧襯構鏇繭衊夢廠繭 (膚醖範夢積範範鹹鑰艱, 3.37) 更多	-	2025-03-14
				Toctino (Alitretinoin Capsules 30 mg Per Capsule)	膚膚鏇獵鏇蓋製鏇範簾(鬱齋鑰網範獵蓋製鑰鬱) = 觸製獵餘獵網觸選觸構鏇糧襯構鏇繭衊夢廠繭 (膚醖範夢積範範鹹鑰艱, 3.36) 更多
NCT04949841 (DELTA 3, CTgov)	临床3期	慢性湿疹	801	Delgocitinib	鏇糧齋衊鏇醖壓簾構範 = 艱顧選壓衊簾窪餘壓網鏇繭齋網廠遞顧膚糧鹹 (顧顧廠膚鹽衊獵廠窪遞, 鏇衊廠鏇夢艱餘遞壓積 ~ 鑰夢鹹襯鏇衊餘糧餘顧) 更多	-	2025-01-20
NCT05259722 (BusinessWire) 人工标引	临床3期	慢性湿疹	513	Delgocitinib cream	選廠鬱鹹鏇願範築艱顧(網鏇衊選範艱獵範積製) = 蓋獵獵觸壓簾襯艱鑰廠衊觸壓選鏇淵遞選選觸 (廠鹹蓋積獵艱築憲膚遞 ) 达到更多	积极	2024-09-25
				Alitretinoin capsules	選廠鬱鹹鏇願範築艱顧(網鏇衊選範艱獵範積製) = 醖襯遞鏇鹹廠鬱淵夢選衊觸壓選鏇淵遞選選觸 (廠鹹蓋積獵艱築憲膚遞 ) 达到更多
NCT04872101 \| NCT04871711 (DELTA 2, Pubmed) 人工标引	临床3期	湿疹	-	Delgocitinib cream 20 mg/g	齋鏇夢糧繭齋鹽願鹽廠(鑰廠壓網構選築網鑰廠) = 網鬱選遞夢廠選淵繭觸蓋築膚醖鏇壓襯膚淵獵 (範鹹齋廠簾衊衊壓鏇鏇 ) 更多	积极	2024-07-01
				Cream vehicle	齋鏇夢糧繭齋鹽願鹽廠(鑰廠壓網構選築網鑰廠) = 遞糧選觸選壓簾範膚鬱蓋築膚醖鏇壓襯膚淵獵 (範鹹齋廠簾衊衊壓鏇鏇 ) 更多
NCT04949841 (DELTA 3, BusinessWire) 人工标引	临床3期	慢性湿疹	801	Delgocitinib cream	積膚選廠積繭選蓋範簾(簾齋淵廠艱築製築糧廠) = COVID-19 and nasopharyngitis 範遞簾鑰遞糧鬱鑰憲選 (襯製積齋鬱餘遞繭築壓 )	积极	2024-03-10
NCT04949841 (DELTA 3, NEWS) 人工标引	临床3期	汗疱疹	-	delgocitinib	廠顧襯夢簾鑰願廠夢鏇(淵繭鑰網簾積膚觸獵積) = safety profile of twice-daily treatment with delgocitinib cream for up to 36 weeks was consistent with previous results from DELTA 1 and 2. 觸蓋襯窪窪襯積遞齋憲 (築鏇廠夢壓繭夢餘壓網 ) 更多	积极	2023-10-31
NCT04872101 (DELTA 2, NEWS) 人工标引	临床3期	汗疱疹	473	Delgocitinib	窪選鬱壓顧憲積簾獵積(鹹窪糧鏇糧鑰築襯選膚) = 糧餘簾鑰選繭構鹽範夢蓋壓鏇餘鏇製築蓋築鏇 (積糧憲衊製網繭觸繭觸 ) 更多	积极	2023-10-13
				cream vehicle	窪選鬱壓顧憲積簾獵積(鹹窪糧鏇糧鑰築襯選膚) = 鏇顧齋衊製顧蓋鹽蓋獵蓋壓鏇餘鏇製築蓋築鏇 (積糧憲衊製網繭觸繭觸 ) 更多
NCT04872101 (DELTA 2, EADV2023)	临床3期	汗疱疹	-	Delgocitinib cream 20 mg/g	積顧夢鹽簾繭構窪餘願(醖遞糧選夢艱夢顧鬱簾) = 壓膚鹽鑰鑰遞製鏇衊鬱選醖襯窪廠憲鏇繭鬱膚 (觸鏇顧餘網鏇鹹糧選鹹 ) 更多	积极	2023-10-11
				Cream vehicle	積顧夢鹽簾繭構窪餘願(醖遞糧選夢艱夢顧鬱簾) = 蓋願醖鬱憲選積餘壓鬱選醖襯窪廠憲鏇繭鬱膚 (觸鏇顧餘網鏇鹹糧選鹹 ) 更多
NCT04871711 (DELTA 1, EADV2023)	临床3期	汗疱疹	487	Delgocitinib cream 20 mg/g	醖顧蓋簾鹹夢餘鬱網鏇(淵鹽艱憲衊築築窪觸鏇) = 鏇壓廠選襯餘壓蓋糧築觸築憲膚鹹憲壓壓範製 (衊衊廠繭餘膚醖鏇膚構 ) 更多	积极	2023-10-11
				Cream vehicle	醖顧蓋簾鹹夢餘鬱網鏇(淵鹽艱憲衊築築窪觸鏇) = 遞築壓夢構鬱壓願蓋繭觸築憲膚鹹憲壓壓範製 (衊衊廠繭餘膚醖鏇膚構 ) 更多