列表页top

您现在的位置:新闻首页>综合资讯

Galderma Announces Positiv

2022-06-23 01:41中华都市报道网总编辑:百网联盟人气:


Galderma Announces Positive Data From Phase III Trial, Demonstrating Efficacy and Safety of nemolizumab in Patients with Prurigo Nodularis

Prurigo nodularis is a rare, potentially debilitating, inflammatory skin disease characterized by disfiguring skin nodules often covering extensive areas of the body, and an intense and chronic itch
There are currently no approved therapeutic options
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a key neuroimmune cytokine involved in the pathogenesis of prurigo nodularis
This phase III trial met both primary endpoints, confirming nemolizumab monotherapy significantly improved skin lesions and pruritus (itch) in adult prurigo nodularis patients
The trial also met all key secondary endpoints, with a safety profile consistent with the phase II trial results


    ZUG, Switzerland -- (BUSINESS WIRE) -- 

    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.” 

      

    FLEMMING RNSKOV, M.D., MPH 

    CHIEF EXECUTIVE OFFICER 

    GALDERMA 

      

    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. 

    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 results of OLYMPIA 2 provide further evidence that nemolizumab effectively improves skin lesions and pruritus in patients with prurigo nodularis. We are encouraged by the strength of these data, that once again highlight the potential of nemolizumab for patients living with this severe and chronic disease.” 

      

    PROFESSOR SONJA STNDER 

    LEAD INVESTIGATOR AND PROFESSOR, DERMATOLOGY 

    UNIVERSITY HOSPITAL MUENSTER 

    GERMANY 

        

    A second phase III trial investigatin