ZUG, SWITZERLAND -- Galderma (SIX: GALD), the pure-play dermatology category leader, 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.