Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin
Systemic Sclerosis (SSc) is a life-threatening autoimmune disease that causes severe inflammation and fibrosis, while Chronic Pruritus of Unknown Origin (CPUO) is characterized by a persistent, chronic itch with an unknown cause 1-3
Nemolizumab is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31. It is approved for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world 4-6
IL-31 is a neuroimmune cytokine that is involved in inflammation and fibrosis – both hallmarks of SSc – and drives itch, a key symptom of CPUO 1,3,4
Enrollment for Galderma's phase II studies of nemolizumab is planned to begin in H2 2025
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Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the initiation of two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients living with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO) – two chronic conditions with high unmet need.1-3,7
Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a role in driving itch – the main symptom of CPUO – and inflammation and fibrosis, which are hallmarks of SSc.1,3,4
'Investigating nemolizumab in two new trials in Systemic Sclerosis and Chronic Pruritus of Unknown Origin, both of which are associated with poor patient outcomes and low quality of life, underscores our commitment to addressing skin conditions with high unmet needs. These trials may help us better understand these complex diseases and offer hope for patients seeking relief from these severe and potentially life-threatening conditions.'
BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA
Systemic Sclerosis (SSc)
SSc is a rare, potentially fatal autoimmune disease that causes inflammation and fibrosis (hardening) of the skin and internal organs.1 It most commonly affects women between the ages of 30 and 50 years old, often leading to a lower quality of life and a much higher risk of death compared to healthy people of the same age.2,8 Currently, there are no approved therapies that address the disease as a whole, highlighting the urgent need for effective treatments.1,2,8
Galderma's phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of nemolizumab in adults with SSc. Patient enrollment is planned to begin in H2 2025, with completion anticipated in 2028. This trial represents a significant step towards addressing the remaining unmet treatment needs in SSc and demonstrates Galderma's commitment to driving progress for patients living with this disease.
The study was designed in collaboration with a Steering Committee of world-leading rheumatology and dermatology experts, including lead trial investigator, Professor Oliver Distler, M.D., Zürich, Switzerland; Professor Dinesh Khanna, M.D., Director of the Scleroderma Program, University of Michigan, United States (U.S.); Professor Robert Spiera, M.D., Director of the Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery, New York, U.S.; and Professor Johann Gudjonsson, M.D., PhD, Dermatologist, University Hospital Michigan, U.S.
The trial is expected to be conducted in several countries in North America, Europe and South America. More information about the study will be made available soon on the clinicaltrials.gov website.
'Systemic Sclerosis can have a profound impact on both the quality and length of a person's life. It causes the skin to harden, damages blood vessels, leads to joint pain, and can result in serious fibrosis in multiple internal organs, sometimes with life-threatening consequences. With no currently approved treatments that are indicated to treat the several symptoms this autoimmune disease presents, I look forward to investigating the role that nemolizumab could potentially play in this condition.'
PROFESSOR OLIVER DISTLER, M.D.
LEAD INVESTIGATOR: SYSTEMIC SCLEROSIS PHASE II STUDY
ZÜRICH, SWITZERLAND
Chronic Pruritus of Unknown Origin (CPUO)
CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause and mostly affects the elderly.3 The chronic and persistent itch is often described as being as debilitating as chronic pain, leading to reduced quality of life and affecting sleep patterns and mood.3,7 There are currently no approved treatments for this condition.3
Galderma's new phase II CPUO trial reinforces the company's commitment to exploring options for patients with chronic skin conditions that significantly impact quality of life. This randomized, double-blind, placebo-controlled proof-of-concept study will explore the pharmacokinetics and pharmacodynamics of nemolizumab in adults. Enrollment is expected to start in H2 2025 in the U.S., with completion anticipated in 2026. The study was designed in collaboration with a Steering Committee of world-leading dermatology experts, including the lead investigator Dr. Shawn Kwatra, M.D., PhD., Joseph W. Burnett Endowed Professor, Chairman of Dermatology, University of Maryland School of Medicine, U.S., and Dr. Sarina Elmariah, MD, PhD, MPH, Associate Professor and Dermatology Director at the Center for Itch and Neurosensory Disorders at the University of California in San Francisco, U.S.
The study is being conducted in the U.S. and more information about the study will be made available soon on the clinicaltrials.gov website.
'It is challenging to treat Chronic Pruritus of Unknown Origin as physicians have limited therapeutic options specifically targeting the underlying cause of itch. With the extensive data showing that IL-31 is a key driver of itch, I'm excited to explore whether nemolizumab's inhibition of IL-31 signaling might effectively reduce the intractable itch experienced by patients with Chronic Pruritus of Unknown Origin.'
DOCTOR SHAWN KWATRA, M.D., PHD
LEAD INVESTIGATOR, CHRONIC PRURITUS OF UNKNOWN ORIGIN PHASE II STUDY
JOSEPH W. BURNETT ENDOWED PROFESSOR
CHAIRMAN OF DERMATOLOGY, UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, U.S.
About nemolizumab
Nemolizumab was approved in August 2024 by the U.S. Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.5 In December 2024, it was also approved by the U.S. FDA for the treatment of 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, nemolizumab 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.
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.9,10
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
1. Jimenez SA, Mendoza FA, Piera-Velasquez S. A review of recent studies on the pathogenesis of Systemic Sclerosis: focus on fibrosis pathways. Front Immunol. 2025;16: 1551911. doi: 10.3389/fimmu.2025.1551911
2. Truchetet ME, et al. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol. 2021;64(3): 262–283. doi: 10.1007/s12016-021-08889-8
3. Teresa J, et al. Therapeutics in chronic pruritus of unknown origin. Itch. 2023;8(1): pe64. doi: 10.1097/itx.0000000000000064
4. 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
5. Nemluvio® U.S. Prescribing Information. Available online. Accessed June 2025
6. Nemluvio® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed June 2025
7. Andrade E, et al. Interventions for chronic pruritus of unknown origin. CDSR. 2020;1(1): CD013128. doi: 10.1002/14651858.CD013128.pub2
8. Scleroderma & Systemic Sclerosis. National Health Service. Available online. Accessed June 2025
9. 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 June 2025
10. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed June 2025
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