Galderma, a key player in the dermatology field globally, has revealed the complete results of the phase III OLYMPIA 1 trial — a 24-week examination of nemolizumab’s effectiveness and safety in adults with moderate-to-severe prurigo nodularis — in JAMA Dermatology.
The trial successfully reached its primary and all significant secondary goals, demonstrating that nemolizumab recipients experienced remarkable advancements in itch and skin lesions at week 16 compared to placebo recipients, with notable and clinically significant responses in itch and sleep disturbances observed by week 4. Nemolizumab was generally well-tolerated, maintaining a safety profile similar to prior studies.
The findings, together with data from the OLYMPIA 2 trial, laid the foundation for the recent FDA approval of nemolizumab for adult prurigo nodularis treatment in the U.S., suggesting the treatment’s capacity to substantially and quickly alleviate the primary bothersome symptom of prurigo nodularis — itch.
The OLYMPIA 1 trial enrolled 286 adult participants with this condition, showing that those administered with nemolizumab without additional topical steroids or inhibitors experienced statistically significant improvements in primary endpoints versus placebo. After 16 weeks, more than triple the number of nemolizumab patients saw positive outcomes.
Significantly, a greater number of those treated with nemolizumab achieved an itch-free or nearly itch-free situation as soon as week 4 compared to those given a placebo.
Nemolizumab, an innovative monoclonal antibody, specifically targets and inhibits IL-31 receptor alpha, a neuroimmune cytokine heavily linked to the symptoms of prurigo nodularis.
These data supported by the OLYMPIA 2 trial underscore nemolizumab’s effectiveness in providing quick and lasting improvements in symptoms such as skin lesions, itch, and disrupted sleep — observable by weeks 16 and 24.
Patients experienced at least a four-point itch intensity improvement on the peak-pruritus numerical rating scale when compared to placebo (58.4% vs 16.7%; P<0.001), achieving significant relief. Achievement of near-clearance or clearance of skin lesions assessed through the investigator's global assessment was markedly higher in the treatment group when compared to placebo (26.3% vs 7.3%; P<0.01). Exploring the improvement in sleep disturbance, nemolizumab patients scored significantly better than placebo recipients (31.1% vs 5.2%; P<0.001), with continued improvements through week 16 (50.0% vs 11.5%; P<0.001). These full results bolster earlier data from the phase III OLYMPIA 2 trial, indicating that nemolizumab meaningfully improved itch and skin lesions in prurigo nodularis patients, with prompt responses appearing as early as week 4. As the most extensive phase III program for prurigo nodularis completed to date, the OLYMPIA trials, including an open-label extension study, serve as a crucial body of evidence. The detailed findings support nemolizumab’s potential to safely alleviate severe symptoms like chronic itch, skin nodules, and poor sleep quality, which deeply impact quality of life and mental health. Driven by the OLYMPIA trial outcomes, nemolizumab, branded as Nemluvio, gained FDA approval for adult prurigo nodularis treatment. Galderma is also pursuing marketing approval for nemolizumab in atopic dermatitis across various regulatory bodies, such as the EMA and the Access Consortium, including countries like Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, with ongoing submissions elsewhere. The FDA has also begun reviewing Galderma’s BLA for nemolizumab for managing moderate-to-severe atopic dermatitis in adolescents and adults, hoping for a decision by year-end. Additionally, Galderma is advancing its marketing authorization for nemolizumab in both prurigo nodularis and atopic dermatitis with international regulatory authorities.