Galderma Announces Clinical Trials Evaluating Nemolizumab for SSc and CPUO

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This week, Galderma announced the initiation of 2 new clinical trials for nemolizumab (Nemluvio), which will be evaluated for the treatment of Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO).¹ Both of these conditions have high unmet need and the interleukin-31 receptor inhibitor targets itch, inflammation, and fibrosis, key symptoms of both conditions. Nemolizumab is currently approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe atopic dermatitis and prurigo nodularis.2

“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, MD, PhD, Global Head of R&D at Galderma, said in a statement.¹

Systemic Sclerosis

SSc is a rare autoimmune disease that causes inflammation and hardening of the skin and internal organs. It most commonly affects female patients between the ages of 30 and 50 years. Patients have a much lower quality of life and have a much higher risk of death. SSc currently has no therapies approved by the FDA.

The phase 2 proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the pharmacokinetics and pharmacodynamics of nemolizumab in adult patients with SSc. Patient enrollment begins later this year and will be completed in 2028, involving sites in several countries across North America, Europe, and South America.

A Steering Committee of several dermatology experts have designed the trial including lead investigator Oliver Distler, MD, from Zürich, Switzerland; Dinesh Khanna, MD, Director of the Scleroderma Program at the University of Michigan, Robert Spiera, MD, Director of the Scleroderma, Vasculitis and Myositis Center at the Hospital for Special Surgery in New York; and Johann Gudjonsson, MD, PhD, dermatologist at the University Hospital of Michigan.

“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,” Distler said in a statement.¹

Chronic Pruritus of Unknown Origin

CPUO, which mostly affects elderly patients, is categorized by itch lasting for over 6 weeks with no probable cause. The debilitating pain can have severe impacts on mood, sleep, and overall quality of life. This condition also does not have any FDA-approved treatments.

The phase 2 CPUO trial is a randomized, double-blind, placebo-controlled proof-of-concept study that will further explore the pharmacokinetics and pharmacodynamics of nemolizumab in adult patients. Patient enrollment in the US begins later this year and will be completed in 2026.

Several experts in the field have collaborated on this research, including 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 and Shawn Kwatra, MD, PhD, Joseph W. Burnett endowed professor and chairman of dermatology at the University of Maryland School of Medicine.

“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,” Kwatra said.¹

References

1. Galderma initiates two new clinical trials investigating nemolizumab in patients with Systemic Sclerosis and Chronic Pruritus of Unknown Origin. News release. Galderma. June 25, 2025. Accessed June 26, 2025. https://www.galderma.com/news/galderma-initiates-two-new-clinical-trials

2. Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 14, 2024. Accessed June 26, 2025. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic