Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101 for moderate to severe atopic dermatitis in adults, demonstrating significant efficacy and safety [1][2] Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 participants [1] - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, with daily administration for 12 weeks [1] - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and the Investigator's Global Assessment (IGA) response [1] Group 2: Efficacy Results - Results showed significant efficacy across all dosage groups, with EASI scores decreasing notably from week 1 [2] - At week 12, the EASI score changes from baseline were -81.98% for the 20mg group, -79.87% for the 40mg group, and -87.85% for the 60mg group [2] - EASI75 response rates were 78.0%, 80.0%, and 84.0% for the respective dosage groups, while IGA response rates were 46.0%, 52.0%, and 68.0% [2] Group 3: Safety and Next Steps - The overall safety and tolerability of TUL01101 were good, with the most common adverse event being upper respiratory infection, mostly mild to moderate in severity [2] - No new safety signals were reported beyond those associated with similar products [2] - The successful completion of Phase II trials supports the initiation of Phase III clinical trials, which are currently being launched in China for moderate to severe atopic dermatitis [2]
联邦制药(03933.HK)：附属创新药TUL01101片II期临床达标 计划开展III期试验