Phase III OLYMPIA 2 trial of CIM 331 shows benefits in prurigo nodularis.

Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvement in both primary endpoints compared to placebo after 16 weeks of treatment: 38 percent of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score, compared to 11 percent in the placebo group (p<0.0001). 56 percent of nemolizumab-treated patients achieved an at least four-point reduction in itch, as measured by the peak-pruritus numerical rating scale (pp-nrs) score, compared to 21 percent in the placebo group (p><0.0001). the trial also met all key secondary endpoints. data confirm early onset of action on itch, skin lesions and sleep disturbance. nemolizumab demonstrated a favorable benefit-risk balance in this trial. the safety profile was consistent with the phase ii trial results.

A second phase III trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing. The OLYMPIA 1 trial has a similar design to OLYMPIA 2. 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.