New tyrosine kinase 2 inhibitor shows Promising Safety and Efficacy in Atopic Dermatitis: JAMA
A new study published in the Journal of the American Medical Association showed that in the treatment of atopic dermatitis (AD), once-daily oral ICP-332, a tyrosine kinase 2 inhibitor, showed significant clinical effectiveness and an acceptable safety profile.
A new treatment drug called ICP-332 is intended to modify important inflammatory pathways that contribute to the pathophysiology of atopic dermatitis. According to preliminary clinical research, ICP-332 maintains a tolerable safety profile while significantly reducing disease severity as determined by standardized clinical indicators. Thus, this research assessed the safety and effectiveness of ICP-332 for mild to severe AD.
This investigation was carried out in 19 Chinese locations between February 6 and November 7, 2023. Those between the ages of 18 and 75 who had been diagnosed with AD for at least a year and had a history of topical therapy contraindication or poor response were included. For four weeks, participants were randomly assigned to take either 80 mg or 120 mg of ICP-332 or a placebo orally once daily.
The group assignment was concealed from study participants and staff. Safety was the main result. The percentage change from baseline in the Eczema Area and Severity Index (EASI) at week four was the primary effectiveness outcome. The percentage of patients who achieved EASI-75 (a ≥75% improvement in EASI) and the Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with two or more points improvement were additional outcomes.
75 participants (mean age 37–45 years; 72% males) participated in this randomized investigation. 68% of placebo, 76% of 80-mg ICP-332, and 75% of 120-mg ICP-332 patients experienced treatment-emergent adverse events, which were primarily mild to moderate and most frequently included lower fibrinogen levels.
At week four, EASI scores dropped by 78.2% and 72.5% with 80 mg and 120 mg ICP-332, respectively, compared to 16.7% with a placebo (P <.001). When compared to a placebo, both dosages had substantially greater EASI-75 response rates (64%). Overall, ICP-332 showed a positive safety profile and promising effectiveness in this phase 2 randomized clinical study, suggesting additional research for AD.
Source:
Xu, J., Zhang, L., Liang, Y., Ji, C., Xu, A., Li, Z., Li, L., Lei, T., Zhang, C., Chen, R., Tao, X., Zhang, R., Fang, H., Zheng, J., Yang, W., Zhang, G., Duan, X., Ding, Y., Yin, W., … Du, Y. (2026). Safety and efficacy of ICP-332 for moderate to severe Atopic Dermatitis: A phase 2 randomized clinical trial. JAMA Dermatology (Chicago, Ill.). https://doi.org/10.1001/jamadermatol.2025.5295
