Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II clinical study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, with treatment administered once daily 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 Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved EASI scores, with reductions of -81.98%, -79.87%, and -87.85% for the 20mg, 40mg, and 60mg groups, respectively, compared to baseline [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]. - The overall safety profile of TUL01101 was favorable, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].
联邦制药(03933)：TUL01101片已完成中重度特应性皮炎成人受试者中的II期临床研究