Galderma Initiates Phase II Trial of Nemolizumab for Chronic Pruritus of Unknown Origin
Key Insights
Galderma has enrolled the first patient in a phase II study investigating nemolizumab for Chronic Pruritus of Unknown Origin (search) (CPUO (search)), an underdiagnosed condition affecting nearly 30% of elderly populations in certain areas.
The randomized, double-blind, placebo-controlled trial builds on recent research showing significant increases in IL-31 (search)-producing CD4+ T cells in CPUO (search) patients, reinforcing IL-31 as a key disease driver.
Nemolizumab, a monoclonal antibody targeting the IL-31 receptor alpha (search), is already FDA-approved for prurigo nodularis (search) and moderate-to-severe atopic dermatitis (search), conditions where IL-31 (search) plays a central role in driving itch.
Galderma has enrolled the first patient in a phase II clinical trial evaluating nemolizumab for the treatment of Chronic Pruritus of Unknown Origin (search) (CPUO (search)), marking a significant step toward addressing an underserved patient population with no approved therapeutic options. The first patient was enrolled at Dr. Vlada Groysman's site in Birmingham, Alabama.
Targeting an Underdiagnosed Condition
CPUO (search) is defined as itch lasting for more than six weeks without an identified cause and represents a common but underdiagnosed condition. The disease is prevalent in nearly 30% of the elderly in certain populations, yet despite its debilitating impact on sleep, mental health, and overall quality of life, there are currently no approved treatments available.
The randomized, double-blind, placebo-controlled phase II study will determine the therapeutic potential of nemolizumab in adults with CPUO (search) to support progression to late-stage development. Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha (search), inhibiting the signaling of IL-31 (search), a neuroimmune cytokine that plays a key role in CPUO by driving itch, its main symptom.
New Research Reinforces IL-31's Role
Galderma's study builds on recent investigation into the causes of inflammation in CPUO (search), which uncovered critical insights into its complex inflammatory profile. The research, presented at the Society of Investigative Dermatology annual meeting in San Diego in May 2025, found a significant increase in IL-31 (search)-producing CD4+ T cells in CPUO patients, reinforcing IL-31 as a key driver of the disease. These results open the door to targeted therapies that address the root causes of CPUO, a disease with significant unmet needs.
Established Track Record in Itch-Related Conditions
Nemolizumab has demonstrated clinical success in related dermatological conditions where IL-31 (search) plays a central role. The drug was approved in August 2024 by the U.S. FDA for the treatment of adults with prurigo nodularis (search). In December 2024, it received additional FDA approval for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis (search), in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
To date, nemolizumab is approved for both moderate-to-severe atopic dermatitis (search) and prurigo nodularis (search) 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.
Development Partnership and Global Reach
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 (search)® and is approved for the treatment of prurigo nodularis (search), as well as pruritus associated with atopic dermatitis (search) in pediatric, adolescent, and adult patients.
The current phase II trial represents Galderma's continued commitment to addressing unmet needs in dermatology, particularly in conditions characterized by chronic itch where IL-31 (search) signaling plays a pathogenic role.