此次欧盟批准基于奈莫利珠单抗的多项Ⅲ期临床试验,包括OLYMPIA 1和OLYMPIA 2试验。这是迄今为止在结节性痒疹中进行的最大规模的临床试验项目,也是唯一一个包括长期扩展研究的项目。 这些全球性、随机、双盲、安慰剂对照的Ⅲ期临床试验评估...
In the trial, nemolizumab demonstrated significant and clinically meaningful improvements in itch and skin nodules at week 16, with rapid reductions in itch observed as early as week 4 in some patients.1 Additionally, the phase 3 OLYMPIA 1 (NCT04501666) and OLYMPIA 2 (NCT04501679) trials ...
The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension stud...
The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. These gl...
The 2023 American Academy of Dermatology (AAD) Annual Meeting will see the data premiere of the phase III OLYMPIA 2 trial, where nemolizumab monotherapy met all primary and key secondary endpoints and demonstrated significant improvements on itch, skin clearance and sleep disturbance in adult patien...
rapid onset of action on itch as early as week 4 (41.1% compared to 6.3% in the placebo group; p<0.0001), and improvements in itch and skin lesions were observed up to week 24. Nemolizumab was well tolerated, and its safety profile was consistent with OLYMPIA 2 trial results.2 ...
(PP-NRS) score of ≥7 on a scale of 0 to 10, and greater than or equal to 20 nodular lesions. OLYMPIA 1 and OLYMPIA 2 assessed the effect of NEMLUVIO on the signs and symptoms of PN, targeting improvement in skin lesions and pruritus over 16 weeks. In OLYMPIA 1, subjects were ...
secondary endpoints, confirming rapid reduction of itch due to prurigo nodularis, and sleep disturbance, within four weeks of treatment initiation.1,15,16Nemluvio was generally well tolerated, and its safety profile was consistent with the phase II trial, and between the OLYMPIA 1 a...
Building on the results ofOLYMPIA 1andOLYMPIA 2, the OLYMPIA open-label LTE study is an ongoing 184-week trial to evaluate the long-term efficacy and safety of nemolizumab monotherapy (without topical corticosteroids) in patients with moderate to severe prurigo nodularis who had received nemoli...
rapid onset of action on itch as early as week 4 (41.1% compared to 6.3% in the placebo group; p<0.0001), and improvements in itch and skin lesions were observed up to week 24. Nemolizumab was well tolerated, and its safety profile was consistent with OLYMPIA 2 trial results.2 ...