開拓藥業-B(09939.HK):KX-826治療脫髮的長期安全性III期臨牀試驗達到主要終點
格隆匯3月20日丨開拓藥業-B(09939.HK)發佈公告,其自主研發、潛在同類首創的KX-826酊治療脫髮的長期安全性III期臨牀試驗已獲得頂線數據。數據顯示,該項長期安全性臨牀試驗達到主要研究終點,結果具有統計學顯着性及臨牀意義,且安全性和有效性均表現出色。
該項長期安全性臨牀試驗是一項多中心、開放標籤研究,旨在評估KX-826外用治療中國脫髮患者的長期安全性(治療時間52周)。該項長期安全性臨牀試驗在全國16家臨牀研究中心開展,由北京大學人民醫院張建中教授擔任主要研究者。該試驗的主要終點是研究過程中出現的不良事件(“TEAE”)的發生情況,次要終點包括目標區域非毳毛數量(“TAHC”)較基線變化等有效性指標和其他安全性指標。此試驗選用KX-826酊0.5%BID(即每日兩次)作爲研究藥物給藥劑量。
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