Galderma’s nemolizumab has been shown to improve the core signs and symptoms of prurigo nodularis, according to phase 3 results published in JAMA Dermatology.

The 24-week OLYMPIA 1 trial evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe cases of the chronic skin condition.

The study met both its primary and all key secondary endpoints, demonstrating that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions compared to those receiving placebo at week 16, with clinically meaningful responses in itch and sleep disturbance observed from week four.

After 16 weeks of treatment, 58.4% of patients randomised to receive nemolizumab achieved at least a four-point improvement in itch intensity compared to 16.7% of those in the placebo group.

Clearance or almost-clearance of skin lesions was achieved by 26.3% of nemolizumab-treated patients versus 7.3% of those in the placebo arm.

Prurigo nodularis is estimated to affect up to 181,000 people in the US and is characterised by intense itch and thick skin nodules covering large body areas.

Nemolizumab is designed to address the underlying cause of the disorder by inhibiting signalling of the neuroimmune cytokine IL-31.

The publication came three months after nemolizumab was approved by the US Food and Drug Administration under the brand name Nemluvio to treat adults with prurigo nodularis.

The regulator’s decision was supported by the results from OLYMPIA 1, as well as the phase 3 OLYMPIA 2 trial, which also showed rapid and significant improvements in itch and skin lesions in patients receiving nemolizumab.

Galderma has marketing authorisation applications for nemolizumab in both prurigo nodularis and atopic dermatitis under review by multiple regulatory authorities, including the European Medicines Agency.

In the company’s latest announcement, Baldo Scassellati Sforzolini, global head of research and development at Galderma, said: “We are committed to bringing this treatment option to patients in other parts of the world as soon as possible.”