Phase 2 trial testing nemolizumab for SSc slated to launch soon
Therapy for skin conditions aims to ease inflammation, scarring in scleroderma
Galderma is launching a Phase 2 clinical trial to test nemolizumab, an antibody the company is developing to ease inflammation and scarring, known medically as fibrosis, in systemic sclerosis (SSc).
Recruitment is planned to begin in North America, South America, and Europe in the second half of this year, with trial completion anticipated in 2028, according to a company press release.
The goal, per Galderma, is to test the therapy’s safety and early efficacy in adults with SSc. Participants will be randomly assigned to receive either the antibody or a placebo.
The researchers also will look at pharmacokinetics, or how nemolizumab moves into, through, and out of the body, as well as pharmacodynamics — the treatment’s effects in the body.
The company is also launching a separate Phase 2 clinical trial of nemolizumab for chronic pruritus of unknown origin, or CPUO, a skin condition characterized by persistent itching lasting longer than six weeks. CPUO has no known cause and no approved treatments.
“Investigating nemolizumab in two new trials … underscores our commitment to addressing skin conditions with high unmet needs,” said Baldo Scassellati Sforzolini, MD, PhD, Galderma’s global head of research and development. “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.”
In scleroderma, the immune system mistakenly attacks the body’s own tissues, leading to excessive inflammation and fibrosis. As scar tissue accumulates, the skin thickens and hardens, leading to symptoms that can vary widely in severity. SSc can also affect blood vessels and internal organs.
Therapy approved in US, EU for skin conditions marked by inflammation
Oliver Distler, MD, the lead investigator of the SSc study, noted that “systemic sclerosis can have a profound impact on both the quality and length of a person’s life.” In addition to hardening skin, it “damages blood vessels, leads to joint pain, and can result in serious fibrosis in multiple internal organs, sometimes with life-threatening consequences,” Distler added.
Nemolizumab is designed to block part of the receptor for IL-31, a protein that drives inflammation and fibrosis, both SSc hallmarks. IL-31 also contributes to itching, which is common in many skin conditions. By blocking this receptor, nemolizumab is intended to reduce the effects of IL-31 in the body, easing symptoms.
Initially developed by Chugai Pharmaceutical, Galderma now holds exclusive rights worldwide to nemolizumab except in Japan. Maruho holds the rights, in the skin disease area, in Japan.
Nemolizumab is approved as Mitchga in Japan — and as Nemluvio in the U.S. and the European Union — for atopic dermatitis and prurigo nodularis, two skin conditions marked by inflammation and severe itching.
An earlier open-label Phase 2 clinical trial (NCT05214794), sponsored by Maruho in Japan, tested how well nemolizumab reduced skin thickness when given as a subcutaneous, or under-the-skin, injection to six adults with moderate to severe skin hardening due to SSc. However, no data have been shared yet.
Distler, who’s a professor at the University of Zurich in Switzerland, added that “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.”
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