Galderma starts Phase 2 trials of nemolizumab for systemic sclerosis

Overview

Galderma, a pure-play dermatology category leader, has 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 – two chronic conditions with high unmet need.

About Systemic sclerosis

Systemic sclerosis is a life-threatening autoimmune disease that causes severe inflammation and fibrosis, while chronic pruritus of unknown origin is characterized by a persistent, chronic itch with an unknown cause.

About the antibody

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 chronic pruritus of unknown origin – and inflammation and fibrosis, which are hallmarks of systemic sclerosis.

“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.”

Systemic sclerosis: what, impacts, and current therapies

• Systemic sclerosis, 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. 
• Currently, there are no approved therapies that address the disease as a whole, highlighting the urgent need for effective treatments.

The phase II trial

• 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.

Global Experts Lead Collaborative Design of Scleroderma Study

• The study was developed in collaboration with a Steering Committee of internationally recognized experts in rheumatology and dermatology.
• Key contributors include:

- Professor Oliver Distler, Lead Trial Investigator, Zürich, Switzerland
- Professor Dinesh Khanna, Director, Scleroderma Programme, University of Michigan, US
- Professor Robert Spiera, Director, Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery, New York, US
- Professor Johann Gudjonsson, Dermatologist, University Hospital Michigan, US

• This multidisciplinary leadership ensures a rigorous and clinically meaningful study design focused on advancing care for scleroderma patients.
The trial is expected to be conducted in several countries in North America, Europe and South America. 
“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.”

Chronic pruritus

• Chronic pruritus of unknown origin is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause and mostly affects the elderly. 
• 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. 
• There are currently no approved treatments for this condition.

Phase II chronic pruritus

• Galderma’s new phase II chronic pruritus of unknown origin 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 US, 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, Joseph W. Burnett Endowed Professor, chairman of Dermatology, University of Maryland School of Medicine, US, and Dr. Sarina Elmariah, Associate Professor and Dermatology Director at the Center for Itch and Neurosensory Disorders at the University of California in San Francisco, US.

“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.”

Nemolizumab and its approvals

• Nemolizumab was approved in August 2024 by the US FDA for the treatment of adults with prurigo nodularis. 
• In December 2024, it was also approved by the US FDA for the treatment of patients 2 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. 
• 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.

The journey of 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.

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