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IL17A/ Fナノボディソネロキマブがプラーク型牛皮病の患者で,多センター,ランダム化,プラセボ対照,フェーズ2b試験
Kim A Papp1, Mark A Weinberg2, Alun Morris3
1Probity Medical Research, Waterloo, ON, Canada.
Lancet (London, England)
|April 25, 2021
まとめ
プラセボと比較して,ソネロキマブがプラーク型牛皮質症患者にとって有意な臨床的効果を示し,迅速かつ持続的な改善を示し,安全性プロファイルが認められた. 高用量のソネロキマブ (60mgと120mg) は,肌の透明化またはほぼ透明化に特に効果的であることが示されました.
科学分野:
- 免疫皮膚科
- 生物学および治療用タンパク質
- 臨床試験の研究
背景:
- ソネロキマブは,IL- 17A,IL- 17F,およびヒトの血清アルブミンを標的とした新しい三価ナノボディです.
- ナノボディは,カメリッドの重鎖抗体から派生した治療用タンパク質の新種です.
- プラーク型牛皮病は慢性的な炎症性皮膚疾患で,しばしば全身療法が必要です.
研究 の 目的:
- ソネロキマブの有効性,安全性,耐受性を評価する.
- プラセボと4つの投与レジームで sonelokimabを比較する
- 比較的な洞察のためのアクティブ・コントロールとしてセクキヌマブを使用する.
主な方法:
- 313人の中等度から重度のプラーク型牛皮病の成人を対象とした,多センター,ランダム化,プラセボ対照のフェーズ2b試験.
- 参加者は,プラセボ,ソネロキマブ (30 mg,60 mg,120 mgの正常負荷,120 mgの増加負荷),およびセクキンマブ (300 mg) の6つのグループにランダムに分けられました.
- 主要評価項目は,第12週に研究者総合評価 (IGA) スコア0または1を達成した患者の割合でした.
主要な成果:
- 12週目には,すべてのソネロキマブ群でプラセボ群と比較してIGAスコア (0または1) の有意な改善が見られた (p< 0. 0001).
- 高濃度のソネロキマブ (60mgと120mg) は高効率で,IGA 0/ 1 を84. 6%から88. 2%まで達成した.
- 副作用は主に軽度から中度までで,ソネロキマブは52週間にわたってセクキヌマブと同様の安全性プロファイルを示し,管理可能なカンジダ感染はわずかに増加した.
結論:
- ソネロキマブはプラセボよりもプラセボの治療において有意な臨床効果を示した.
- 治療は迅速に効果を発揮し,持続的な改善と許容可能な安全性プロファイルを示した.
- ソネロキマブは,特に120mg以下で,プラーク型牛皮病の有望な治療法です.
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