Latest news with #ChronicHandEczema
Business Wire
6 days ago
- Health
- Business Wire
LEO Pharma Initiates Phase 2a DELTA NEXT Trial of Delgocitinib Cream in Adults with Mild to Severe Palmoplantar Pustulosis (PPP)
BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the initiation of the phase 2a proof-of-concept DELTA NEXT trial. The trial aims to evaluate the efficacy and safety of delgocitinib cream compared to cream vehicle in the treatment of adults with mild to severe Palmoplantar Pustulosis (PPP). PPP is the first disease for which LEO Pharma will investigate delgocitinib cream since completion of the Phase 3 DELTA trials in Chronic Hand Eczema (CHE). ' The DELTA NEXT trial in PPP represents an exciting new chapter in the clinical development journey of delgocitinib cream,' said Christophe Bourdon, Chief Executive Officer, LEO Pharma. 'PPP is a disease with few treatment options that can severely affect quality of life. We are hopeful that this therapy could potentially provide much-needed help for patients suffering from this devastating condition.' PPP is an uncommon, chronic, inflammatory, relapsing skin disease characterized by repeated episodes of sterile pustules alongside erythema, blistering and scaly skin on the palms and/or soles of the feet. 3,4 PPP is associated with a high patient burden, resulting in significant impairment of quality of life. Patients often experience pain, fatigue, and the condition can be triggered by factors such as smoking, infections, and stress. PPP is associated with comorbidities such as thyroid dysfunction and metabolic syndrome. 4 There are currently no approved advanced systemic treatments for PPP in the U.S. or Europe. 5 PPP is associated with complex T-cell activation patterns, which may be why many biologics that target individual T helper cell populations have shown limited efficacy in clinical trials. 6 Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor shown to inhibit the activity of all four JAKs, which are involved in inflammatory signaling. 1,2 Using delgocitinib cream's mechanism of action, the trial will investigate the potential benefit of inhibiting multiple JAKs to treat PPP. 'I've seen firsthand how PPP can severely disrupt patients' lives, making it painful to walk, perform activities of daily living and impacting their ability to work,' said Dr. Robert Bissonnette, international coordinating investigator (ICI) on the DELTA NEXT trial and Chairman at Innovaderm Montreal, Canada. 'Despite the significant burden it places on patients, treatment options remain limited. There is a real and urgent need for effective therapies." The DELTA NEXT trial plans to recruit up to 135 patients with active, chronic, mild to severe PPP for whom topical corticosteroids are inadequate or inadvisable. Participants will be recruited across 40-45 sites in the United States, Canada, the United Kingdom, Germany, and Poland. Currently, delgocitinib cream 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 review in other markets, including the United States. For more information on the DELTA NEXT trial, go to Notes to editors About Delgocitinib Cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor. It prevents the activation of the JAK-STAT pathway by blocking the signaling of several inflammatory cytokines, thereby suppressing the inflammatory cascade and preventing the downregulation of important barrier genes. 7 Delgocitinib cream is currently approved in the European Union, the 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. It is under review in other markets, including the United States. 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. About the DELTA NEXT Trial DELTA NEXT is a phase 2a, randomized, double-blind, two-arm, vehicle control, adaptive design proof-of-concept trial to assess the efficacy and safety of twice-daily delgocitinib cream compared with cream vehicle in adult subjects with mild to severe PPP. The DELTA NEXT trial plans to recruit up to 135 patients with active, chronic, mild to severe PPP for whom topical corticosteroids are inadequate or inadvisable. Participants will be randomized into a 2:1 ratio to receive either delgocitinib cream or cream vehicle. Participants will be recruited across 40-45 sites in the United States, Canada, the United Kingdom, Germany, and Poland. About Palmoplantar Pustulosis (PPP) Palmoplantar Pustulosis (PPP) is an uncommon chronic, inflammatory, relapsing skin disease characterized by repeated episodes of sterile pustules alongside erythema, blistering and scaly skin on the palms and/or soles of the feet. 3,4 The disease is more common in females, with the estimated prevalence ranging from 0.01% to 0.05%. 3,4 The mean age of patients ranges from 40 to 58 years and is often associated with smoking, thyroid-gland abnormalities, and nickel sensitivity. 4,8 PPP is associated with a significant clinical burden. Patients often experience pain, fatigue, and the condition can be associated with hyperlipidemia and high blood pressure. 8 The condition has been shown to have a greater impairment on work and daily life than plaque psoriasis. 8 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 References Tanimoto A, Ogawa Y, Oki C, et al. Pharmacological properties of JTE-052: a novel potent JAK inhibitor that suppresses various inflammatory responses in vitro and in vivo. Inflamm Res. 2015;64(1):41-51. Tanimoto A, Shinozaki Y, Yamamoto Y, et al. A novel JAK inhibitor JTE-052 reduces skin inflammation and ameliorates chronic dermatitis in rodent models: Comparison with conventional therapeutic agents. Exp Dermatol. 2018;27(1):22-29. Kharawala S, Golembesky AK, Bohn RL, Esser D. The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review. Expert Rev Clin Immunol. 2020;16(3):239-252. Misiak-Galazka M, Zozula J, Rudnicka L. Palmoplantar Pustulosis: Recent Advances in Etiopathogenesis and Emerging Treatments. Am J Clin Dermatol. 2020;21(3):355-370. Xu JM, Wang HM, Jin HZ. An update on therapeutic options for palmoplantar pustulosis: a narrative review and expert recommendations. Expert Rev Clin Immunol. 2023;19(5):499-516. McCluskey D, Benzian-Olsson N, Mahil SK, et al. Single-cell analysis implicates TH17-to-TH2 cell plasticity in the pathogenesis of palmoplantar pustulosis. J Allergy Clin Immunol. 2022;150(4):882-893. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges [published correction appears in Ther Clin Risk Manag. 2021 Mar 18;17:233.]. Ther Clin Risk Manag. 2020;16:1319-1332. Lebwohl MG, Medeiros RA, Strober B, et al. Palmoplantar Pustulosis has a Greater Disease Burden than Plaque Psoriasis: Real-World Evidence From the CorEvitas Psoriasis Registry. J Psoriasis Psoriatic Arthritis. 2023;8:56–65.
National Post
24-04-2025
- Health
- National Post
LEO Pharma Announces Publication of Head-to-Head DELTA FORCE Study Results in The Lancet
Article content DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and investigational delgocitinib topical treatment for Chronic Hand Eczema (CHE). 1 Article content Article content TORONTO — 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. Article content 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. Article content Article content 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. Article content 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). Article content Furthermore, patients receiving delgocitinib cream had fewer treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules. Article content '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.' Article content '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.' Article content 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 Article content 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 Article content Article content About Chronic Hand Eczema Article content 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 hands 7 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 Article content 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 Article content 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 Article content 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. Article content 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.
Yahoo
27-02-2025
- Health
- Yahoo
LEO Pharma Meets Primary Endpoint in Phase 3 DELTA China Trial with Anzupgo® (delgocitinib) Cream in Chinese Patients with Moderate to Severe Chronic Hand Eczema (CHE)
The phase 3 clinical trial investigated Anzupgo® in Chinese adults and adolescents (aged 12 and above) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 Upon completion of the double-blind treatment period, the trial met its primary endpoint with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.1 The safety profile and pharmacokinetics (PK) data remained consistent with previous trial findings, with Anzupgo generally well tolerated and with low systemic exposure.1 BALLERUP, Denmark, February 27, 2025--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results for the primary endpoint from the double-blind treatment period of the DELTA China trial. DELTA China is a phase 3 clinical trial with Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adults and adolescents (aged 12 and above) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.1 The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks.1 A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.1 The results announced today cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of Anzupgo treatment and are an important milestone in the Chinese market as there are currently no approved treatment options specifically indicated for moderate to severe CHE in China.1 The primary endpoint for DELTA China was the Investigator's Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.1 Furthermore, the 16-week safety profile of Anzupgo was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.1 The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing.1 The results from this stage of the trial will be released at a later date. The primary objective of the study was to evaluate the efficacy of twice-daily applications of Anzupgo compared with cream vehicle in the treatment of Chinese subjects with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.1 "Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China," said Byron Yin, General Manager for LEO Pharma in China. "LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China." The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.2-5 "DELTA China demonstrates LEO Pharma's truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide," said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition." 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 China are planned to be submitted for scientific presentation and publication at a later date. For more information on the DELTA China trial (NCT06004050) go to Notes to editors About Anzupgo® (delgocitinib) cream 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. Anzupgo® (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.6 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.7 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. About the DELTA China Trial DELTA China is a phase 3 trial to evaluate efficacy, safety, and pharmacokinetics (PK) (only adults) of twice-daily applications of Anzupgo in Chinese adults and adolescents (aged 12 and above) with moderate to severe CHE.1 The primary endpoint of the DELTA China trial was the Investigator's Global Assessment for CHE 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.1 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.8,9 HE is the most common skin disorder of the hands10 with a prevalence rate of approximately 4.7%.11 In a substantial number of patients, HE can develop into a chronic condition.10 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.12 CHE has been shown to cause psychological and functional burdens that impact patient quality of life,13 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.14 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.15 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 References National Library of Medicine (U.S.). Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema. Identifier: NCT06004050. 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. 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. 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. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841 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. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;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. 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. 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. 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. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;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. 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. 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. MAT- 80047 February 2025 View source version on Contacts Jes Broe FrederiksenGlobal Commercial Communication+45 53 60 59 48jebfe@ Jeppe IlkjærGlobal Corporate Communications+45 3050 2014JEILK@ Sign in to access your portfolio
