BEIJING, Jan. 29, 2026 (GLOBE NEWSWIRE) -- JAMA Dermatology recently published the results of a Phase II study of novel TYK2 inhibitor soficitinib (ICP-332) in patients with moderate-to-severe atopic dermatitis (AD). The journal concluded that soficitinib demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD.
This is a double-blind, placebo-controlled, phase 2 randomized clinical trial aiming to evaluate the safety and efficacy of soficitinib for moderate to severe AD. 75 participants were randomized 1:1:1 to receive soficitinib at 80 mg or 120 mg, or placebo orally once daily. The primary endpoint was safety and efficacy. The key efficacy endpoint was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other endpoints included percentages of patients achieving EASI-75 (a =75% improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with 2 or more points improvement.
Soficitinib achieved multiple efficacy endpoints in the study. Percentage improvement from baseline in EASI at week 4 were 78.2% in the 80-mg soficitinib group, 72.5% in the 120-mg soficitinib group, and 16.7% for those receiving placebo. There was a statistically significant higher EASI-75 response rate with both soficitinib doses (64.0% for each; difference vs placebo, 56.0%) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and improvement of 2 or more points at week 4 in the 80-mg soficitinib group vs placebo (36.0%; difference vs placebo, 32.0%, P=0.005).
Meanwhile, soficitinib demonstrated rapid relief of pruritus and significant improvement in quality of life. Substantial reductions in Pruritus NRS severity and frequency scores were observed on day 2 of treatment compared to placebo, with continued improvement over time peaking at week 4 in severity and in frequency (all P<0.05). In both the 80-mg soficitinib and 120-mg soficitinib groups, 18 of 25 patients (72.0%) achieved an improvement of 4 points or more at week 4, compared with 4 of 25 patients (16.0%) in the placebo group (P<0.0001). DLQI from baseline in the soficitinib groups were considerably better than those in the placebo group at weeks 1, 2, and 4.
Soficitinib also showed a good tolerability and safety profile, and treatment-related adverse events (TRAEs) were mild or moderate. All TEAEs in the 80-mg soficitinib group were mild, which is comparable to those receiving placebo.
Professor Jinhua Xu of Huashan Hospital Fudan University said, "In this Phase II randomized clinical trial, soficitinib monotherapy was efficacious and demonstrated a favorable benefit-risk profile. I am delighted that patient enrollment has been completed for the Phase III clinical trial of soficitinib in AD and look forward to benefiting patients as early as possible."
JAMA Dermatology is a leading international academic journal published by the American Medical Association (AMA), focusing on cutting-edge research in dermatology.
Note: The main content of this press release is derived from this published article. Full text can be found in https://jamanetwork.com/journals/jamadermatology/fullarticle/2843770.
About Soficitinib
Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, psoriasis, and more. Patient enrollment has been completed for the Phase III clinical trial of soficitinib in moderate-to-severe AD, with a total of 579 patients enrolled; enrollment has also been completed for the Phase II clinical trial of soficitinib in vitiligo, with a total of 162 patients enrolled.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
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