Swiss independent dermatology specialist Galderma today announced the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. The safety profile was consistent with the Phase II trial results.
“Prurigo nodularis is known to have a profoundly negative impact on quality of life with currently no approved therapeutic options. These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis,” commented Galderma chief executive Dr Flemming Ornskov.
OLYMPIA 2, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, is a pivotal Phase III clinical trial, evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period.
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