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About the ARCADIA clinical trial program17
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The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.
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These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors).
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The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.
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About atopic dermatitis
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is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.
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It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.
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It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.
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About the OLYMPIA clinical trial program22,23
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The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study.
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These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.
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About prurigo nodularis
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is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.
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It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.
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The majority of patients report that the persistent itch negatively impacts their quality of life.
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Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.
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About Galderma
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Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information:
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References:
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- Ständer S, et al. Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis Phase 3 studies. JEADV. 2025 Early View. doi: 10.1111/jdv.70250
- Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1): 173-182. doi: 10.1016/j.jaci.2019.08.013
- Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2
- Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390
- Nemluvio® U.S. Prescribing Information. Available online. Accessed December 2025
- Nemluvio® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed December 2025
- Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: 10.3390/ijms21082867
- Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286- 1
- Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017;23(8 suppl):S115-S123. PMID:28978208
- Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042
- Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi: 10.2340/00015555-3471
- Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722
- Rodriguez D, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol. 2023;159(11):1205-1212. doi: 10.1001/jamadermatol.2023.3251
- Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932
- Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed December 2025
- Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed December 2025
- Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0
- Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911
- Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257
- Luger, T, et al. Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey. Dermatol Ther (Heidelb). 2022;12:949–969. https://doi.org/10.1007/s13555-022-00700-6
- Oisín S, et al. 545 – Prevalence of moderate and severe atopic dermatitis in Ireland: a cross-sectional, real-world study of a secondary care population. BJD. 2024;190(S2):ii43–ii44. https://doi.org/10.1093/bjd/ljad498.045
- Ständer S, et al. Efficacy and Safety of Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;161(2):147-156. doi: 10.1001/jamadermatol.2024.4796
- Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333
- Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183
- Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570
- Ryczek A, et al. Prevalence of Prurigo Nodularis in Poland. Acta Derm Venereol. 2020;100:adv00155. doi: 10.2340/00015555-3518
- Ständer, S, et al. Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis. Acta Dermato-Venereologica. 2020;100(18):1–6. https://doi.org/10.2340/00015555-3655
- Joel MZ, et al. Risk of itch-induced sleep deprivation and subsequent mental health comorbidities in patients with prurigo nodularis: A population-level analysis using the Health Improvement Network. E-poster presented at EADV 2023. Abstract available online
- Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi:10.1056/NEJMe1916733
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Contacts
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For further information:
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Christian Marcoux, M.Sc.
Chief Communications Officer
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+41 76 315 26 50
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Richard Harbinson
Corporate Communications Director
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+41 76 210 60 62
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Céline Buguet
Franchises and R&D Communications Director
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+41 76 249 90 87
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Emil Ivanov
Head of Strategy, Investor Relations, and ESG
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+41 21 642 78 12
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Jessica Cohen
Investor Relations and Strategy Director
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+41 21 642 76 43
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