Soficitinib (ICP-332) Meets Primary Endpoint in Phase 3 Trial for Moderate to Severe AD

Today, InnoCare Pharma shared that the company’s phase 3 trial of soficitinib (ICP-332) met its primary endpoint in patients with moderate to severe atopic dermatitis (AD).¹ Soficitinib is a novel and selective oral tyrosine kinase 2 (TYK2) inhibitor and is currently being developed for the treatment of several dermatologic inflammatory conditions, such as vitiligo, psoriasis, prurigo nodularis, and chronic spontaneous urticaria. It has already demonstrated phase 2 success in AD, with results published in JAMA Dermatology earlier this year.²

Trial Success and Executive Perspectives

The phase 3 study is a randomized, double-blind, placebo-controlled, multicenter registrational clinical trial designed to evaluate the efficacy, safety, and tolerability of soficitinib in approximately 579 participants. The drug achieved its primary endpoint with statistical significance, demonstrating consistent clinically meaningful improvement. Secondary endpoints were also met, and no new safety signals were identified, consistent with previous research. According to InnoCare, detailed data on durability of response, dose optimization, and longer-term safety will be presented at upcoming international scientific congresses and/or in academic journals.

“We are happy to see that soficitinib has met the primary endpoint in the Phase III studies in atopic dermatitis with excellent clinical results,” Jasmine Cui, PhD, co-founder, chairwoman and CEO of the company, said in today’s press release. "AD is a chronic, relapsing inflammatory skin disease characterized by intense pruritus, eczema, and substantial impairment in patients' quality of life. We will continue to complete the Phase III study and plan to advance the regulatory filing to bring better treatment option to patients with atopic dermatitis and other autoimmune diseases.”¹

Phase 2 Study Design

The prior phase 2 trial was a double-blind, placebo-controlled study designed to assess early safety and efficacy signals. A total of 75 participants were randomized in a 1:1:1 ratio to receive oral soficitinib at doses of 80 mg or 120 mg once daily, or matching placebo, over a 4-week treatment period. Baseline disease severity reflected a population with clinically meaningful disease activity. The primary objective was to evaluate safety and efficacy, with the key efficacy endpoint defined as the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4. Secondary and exploratory endpoints included the proportion of patients achieving EASI-75, improvements in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), pruritus outcomes, and patient-reported quality of life measures.

Existing Efficacy and Safety Outcomes

At week 4, researchers found both soficitinib dose groups demonstrated substantial reductions in disease severity compared with placebo. Mean percentage improvement from baseline in EASI was 78.2% in the 80 mg group and 72.5% in the 120 mg group, compared with 16.7% in the placebo arm. These changes translated into clinically relevant response rates, with 64.0% of patients in each soficitinib group achieving EASI-75, versus a markedly lower response in the placebo group. Improvements in global disease assessment were also observed, particularly in the 80 mg group, where a higher proportion of patients achieved a vIGA-AD score of clear or almost clear with at least a 2-point improvement compared with placebo (36.0% vs 4.0%; P=0.005).

MORE ON ATOPIC DERMATITIS

Reductions in pruritus severity and frequency, measured by the Pruritus Numerical Rating Scale, were evident as early as day 2 of treatment in both active treatment arms. Improvements continued over the 4-week period, with peak effects observed at week 4. Notably, 72.0% of patients receiving either dose of soficitinib achieved a reduction of at least 4 points in pruritus severity by week 4, compared with 16.0% in the placebo group. These symptomatic improvements were accompanied by consistent gains in quality of life, as assessed by the Dermatology Life Quality Index (DLQI), with statistically significant differences favoring soficitinib at weeks 1, 2, and 4. Treatment-emergent adverse events were predominantly mild or moderate in severity, and no unexpected safety signals were reported.

“In this Phase II randomized clinical trial, soficitinib monotherapy was efficacious and demonstrated a favorable benefit-risk profile…I look forward to benefiting patients as early as possible,” Jinhua Xu, PhD, professor at Huashan Hospital, Fudan University, said.²

References

1. InnoCare Announces Phase III Study Results of TYK2 Inhibitor Soficitinib Meet Primary Endpoint in Patients with Atopic Dermatitis. News release. Published July 15, 2026. Accessed July 15, 2026. https://www.globenewswire.com/news-release/2026/07/15/3327622/0/en/innocare-announces-phase-iii-study-results-of-tyk2-inhibitor-soficitinib-meet-primary-endpoint-in-patients-with-atomic-dermatitis.html?_gl=1*fspvkx*_up*MQ..*_ga*MTI2ODQ4MjQ0Mi4xNzg0MTIxMjQx*_ga_B6167QB2TF*czE3ODQxMjEyNDEkbzEkZzAkdDE3ODQxMjEyNDEkajYwJGwwJGg1OTQ1NzQ5NzU.*_ga_ERWPGTJ5X8*czE3ODQxMjEyNDEkbzEkZzAkdDE3ODQxMjEyNDEkajYwJGwwJGgw

2. Study results of novel TYK2 inhibitor soficitinib in patients with AD published by JAMA Dermatology. News release. Published January 29, 2026. Accessed July 15, 2026. https://www.biospace.com/press-releases/study-results-of-novel-tyk2-inhibitor-soficitinib-in-patients-with-ad-published-by-jama-dermatology