Zug, Switzerland (June 26, 2025) – Galderma has announced two new Phase II clinical trials to study nemolizumab, a drug designed to block the IL-31 receptor.
These trials will focus on patients with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO), two conditions with high unmet medical needs and no approved treatments available.
What is Nemolizumab?
Nemolizumab is a monoclonal antibody. It works by blocking interleukin-31 (IL-31), a protein that triggers inflammation, fibrosis, and itching in the body. Blocking IL-31 signaling helps reduce severe itch and tissue damage caused by immune system activity.
Nemolizumab is already approved in many countries, including the United States and the European Union, for:
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Atopic Dermatitis (moderate to severe cases)
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Prurigo Nodularis (a skin condition with itchy, painful nodules)
Because IL-31 also drives symptoms of SSc and CPUO, scientists believe the drug could improve outcomes for patients who currently have very limited treatment choices.
Why Focus on Systemic Sclerosis?
Systemic Sclerosis is a rare but serious autoimmune disease. It causes the immune system to attack the body’s own tissues, leading to:
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Hardening and thickening of the skin
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Damage to blood vessels
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Joint stiffness and pain
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Fibrosis (scarring) in internal organs such as the lungs, kidneys, or heart
This disease mostly affects women between the ages of 30 and 50. Patients often face a reduced quality of life and a higher risk of early death. Current medicines only treat some symptoms but do not stop or reverse the disease itself.
Details of the SSc Trial
The new trial will assess the safety and efficacy of nemolizumab in adults with systemic sclerosis (SSc).
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Study type: Randomized, double-blind, placebo-controlled
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Focus: Pharmacokinetics (how the drug moves in the body) and pharmacodynamics (how the drug works in the body)
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Start: Patient enrollment begins in the second half of 2025
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Completion: Expected in 2028
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Regions: Multiple sites across North America, Europe, and South America
The trial has been designed with leading global experts, including Professor Oliver Distler (University of Zurich), Professor Dinesh Khanna (University of Michigan), Professor Robert Spiera (Hospital for Special Surgery, New York), and Professor Johann Gudjonsson (University of Michigan).
Professor Distler explained that systemic sclerosis affects not only how long patients live but also their day-to-day health. He added that because no approved treatment addresses the disease fully, nemolizumab could provide a much-needed breakthrough.
Why Focus on Chronic Pruritus of Unknown Origin?
Chronic Pruritus of Unknown Origin is a skin condition where patients suffer from constant itching lasting more than six weeks without a clear cause. It most commonly affects older people.
The condition is often compared to chronic pain because it is so persistent and distressing. Patients report poor sleep, mood changes, and severe disruptions to their daily lives. CPUO has no approved therapies, leaving doctors with very limited ways to manage it.
Details of the CPUO Trial
Galderma’s CPUO trial will take a closer look at nemolizumab in adults with long-lasting, unexplained itch. The study will not only measure whether nemolizumab reduces itching but also track its effect on quality of life, sleep patterns, and daily function.
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Study type: This is a Phase II, randomized, double-blind, placebo-controlled trial, which means neither doctors nor patients will know who is receiving the real drug or placebo. This design ensures reliable results.
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Focus: Researchers will study how safe nemolizumab is, how the drug behaves inside the body, and whether it truly reduces persistent itch that has no known medical cause.
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Start: Enrollment is set to begin in the United States in late 2025. Researchers will recruit patients who have had an ongoing unexplained itch for more than six weeks.
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Completion: The trial is expected to be completed in 2026, with results made public after review and analysis.
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Locations: The study will be conducted at several major U.S. research centers, allowing diverse patient participation and broader data collection.
The study is led by Dr. Shawn Kwatra, Professor and Chairman of Dermatology at the University of Maryland, with support from Dr. Sarina Elmariah of the University of California, San Francisco.
Dr. Kwatra explained that IL-31 is strongly linked to itch, and blocking this pathway could finally offer relief to patients with CPUO. He also noted that for many patients, persistent itch is just as disruptive and disabling as chronic pain, which makes finding an effective treatment urgent.
Galderma’s Goal with the Trials
Dr. Baldo Scassellati Sforzolini, Galderma’s Global Head of R&D, said these trials reflect the company’s focus on diseases with no available therapies. He noted that both conditions severely reduce quality of life and may even be life-threatening. Testing nemolizumab in these areas could help build a foundation for future treatments and give patients new hope.
About Galderma
Galderma is a dermatology company founded in 1981. It operates in about 90 countries worldwide and focuses only on skin health. The company works across three main business areas:
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Injectable Aesthetics (dermal fillers and other cosmetic treatments)
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Dermatological Skincare (skin health products)
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Therapeutic Dermatology (prescription medicines and advanced treatments)
By launching these new studies, Galderma continues to expand its research into diseases that have long been overlooked.
FAQs
1. What is nemolizumab currently approved for?
Nemolizumab is approved for moderate-to-severe atopic dermatitis and prurigo nodularis. It is used when patients do not respond to standard topical treatments.
2. Why test nemolizumab in SSc and CPUO?
Both conditions lack any approved treatments. Since IL-31 plays a central role in causing inflammation, fibrosis, and itch, researchers believe nemolizumab may reduce symptoms and improve patient outcomes.
3. When will results from the trials be available?
The CPUO trial is expected to finish in 2026, while the SSc trial will run longer and finish in 2028. If results are positive, Galderma may seek regulatory approvals after that.
4. Who can take part in the trials?
Adults diagnosed with Systemic Sclerosis or Chronic Pruritus of Unknown Origin may qualify, depending on the inclusion rules of each trial. Enrollment will begin in the second half of 2025.
5. How important are these studies for patients?
These studies represent a chance to bring the first effective treatments to people who have suffered without options. If nemolizumab proves successful, it could transform care for both SSc and CPUO patients.
