Post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs, published in the Journal of the European Academy of Dermatology and Venereology, highlight nemolizumab’s fast onset of action and improvement of itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis and prurigo nodularis1
Significant improvements in itch were observed as early as 48 hours after initial treatment and steadily increased through to Day 141
Nemolizumab is the first approved monoclonal antibody that specifically targets and inhibits the signalling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in atopic dermatitis and prurigo nodularis2-4
Nemolizumab is approved by multiple regulatory authorities around the world for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis, including in the U.S. and EU5,6
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today released new clinical data confirming nemolizumab’s rapid onset of action on itch and sleep, with significant improvements observed as early as 48 hours after treatment in some patients with atopic dermatitis and prurigo nodularis.1 The findings from post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs were published in the Journal of the European Academy of Dermatology and Venereology.
Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31.2,5,6 IL-31 is a neuroimmune cytokine that drives itch and other symptoms in both atopic dermatitis and prurigo nodularis.3,4 These new findings reinforce the critical role of IL-31 pathway inhibition in achieving rapid itch response.
Atopic dermatitis and prurigo nodularis are debilitating skin conditions that significantly affect quality of life, with symptoms such as persistent itch, skin lesions and poor sleep quality.7-13 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis seeking freedom from itch, and 88% of those with prurigo nodularis rating it as their worst symptom.13,14
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“These new data reinforce our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with atopic dermatitis and prurigo nodularis, as well as its role in targeting the IL-31 pathway. We are proud to be driving innovation that directly addresses the most urgent needs of people living with chronic skin conditions and remain committed to delivering effective, fast-acting and lasting solutions.” AUTHOR AND GLOBAL PROGRAM HEAD THERAPEUTIC DERMATOLOGY GALDERMA |
Rapid relief of itch and sleep disturbance observed within 48 hours
The relevant analyses focused on data from the ARCADIA 1 and 2 trials in atopic dermatitis and the OLYMPIA 1 and 2 trials in prurigo nodularis. During those trials, patients reported itch intensity and sleep disturbance daily. Daily assessments of patients with atopic dermatitis and prurigo nodularis using a ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) and Sleep Disturbance Numerical Rating Scale (SD-NRS) showed that in some patients:
- Nemolizumab reduced itch within two days (atopic dermatitis: 10.7% nemolizumab-treated compared to 2.9% placebo, 95% CI of the difference: 5.6-10.1; P<0.0001; prurigo nodularis: 17.2% nemolizumab-treated compared to 3.7% placebo; 95% CI of the difference: 6.8-16.7; p<0.0001)1
- Nemolizumab improved sleep disturbance within two days (atopic dermatitis: 9.9% nemolizumab-treated compared to 4.6% placebo, 95% CI of the difference: 2.8-7.7; p=0.0001; prurigo nodularis: 13.4% nemolizumab-treated compared to 4.3% placebo; 95% CI - of the difference: 4.0-13.0; p=0.0013)1
- By Day 14, a quarter of patients with atopic dermatitis and more than a third of patients with prurigo nodularis achieved significant and clinically meaningful responses in both itch and sleep outcomes1
Taken individually, each study (ARCADIA 1 and 2 for atopic dermatitis and OLYMPIA 1 and 2 for prurigo nodularis) also demonstrated a significant PP-NRS response at Day 2.1
These new data reinforce nemolizumab’s efficacy and its potential to deliver rapid relief from itch – the most burdensome symptom for many patients with atopic dermatitis and prurigo nodularis.13,14
Media can find more information and resources on atopic dermatitis and prurigo nodularis in this toolkit.
About Nemluvio® (nemolizumab)
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.15,16
Nemluvio was approved by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis, and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.5 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.
About the ARCADIA clinical trial program17
The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.
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).
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.
About atopic dermatitis
Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.7,8,18 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.8,19 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.20,21
About the OLYMPIA clinical trial program22,23
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.
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.
About prurigo nodularis
Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.10,24,25 It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.26,27 The majority of patients report that the persistent itch negatively impacts their quality of life.11 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.28,29
About Galderma
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: www.galderma.com.
References:
- 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
Contacts
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Chief Communications Officer
christian.marcoux@galderma.com
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Corporate Communications Director
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Franchises and R&D Communications Director
celine.buguet@galderma.com
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emil.ivanov@galderma.com
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Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
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