Dermatology specialist Galderma (SWX:GALD) revealed on Wednesday that it has initiated two new phase II clinical trials to evaluate nemolizumab in patients with systemic sclerosis (SSc) and chronic pruritus of unknown origin (CPUO), both conditions with high unmet medical need.
Nemolizumab, a monoclonal antibody that blocks IL-31 receptor alpha signalling, targets inflammation, fibrosis and itch -- key factors in both SSc and CPUO. The drug is already approved by regulatory agencies worldwide for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis.
The systemic sclerosis study is a multicentre, randomised, placebo-controlled trial across North America, Europe and South America, with patient enrolment set for the second half of 2025 and completion expected in 2028.
The CPUO trial will be conducted in the United States, also beginning enrolment in the second half of 2025, with completion anticipated in 2026.
SSc is a rare autoimmune disease causing skin and organ fibrosis, while CPUO presents as persistent itch without a known cause, primarily affecting elderly patients.
Currently, there are no approved treatments for either condition, underscoring the significance of these trials in Galderma's research portfolio.
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