TOPLINE:

ICP-332, an investigational tyrosine kinase 2 inhibitor, demonstrated favorable safety and resulted in more than a 70% reduction in Eczema Area and Severity Index (EASI) scores in a randomized phase 2 trial of patients with moderate-to-severe atopic dermatitis (AD).

METHODOLOGY:

• A double-blind, placebo-controlled phase 2 randomized clinical trial enrolled 75 patients (100% were Asian) with moderate-to-severe AD across 19 centers in China from February to November 2023.
• Participants were randomly assigned 1:1:1 to receive ICP-332 at doses of 80 mg once a day (mean age, 34 years) or 120 mg once a day (mean age, 40.6 years) or placebo (mean age, 44.5 years) orally once daily for 4 weeks.
• The primary outcome was safety; key efficacy endpoints were the percentage change in EASI at week 4, the proportion of patients achieving an EASI-75, and a Validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (clear) or 1 (almost clear) with at least 2 points improvement.

TAKEAWAY:

• Treatment-emergent adverse events, mostly mild, were reported in 76% and 75% of the patients in the 80- and 120-mg dose groups, respectively, compared with 68% in the placebo group; decreased blood fibrinogen was the most common event (24% and 21%, respectively, vs 4% for placebo).
• Percentage reductions in EASI at week 4 were significantly greater in both treatment groups (-78.2% for 80 mg and -72.5% for 120 mg) than with placebo (-16.7%).
• EASI-75 response rates at week 4 were 64% among those receiving ICP-332 (both doses) vs 8% of those receiving placebo (P < .001).
• The 80-mg ICP-332 dose showed greater improvement in vIGA-AD scores, with 36.0% achieving clear or almost clear status with ≥ 2-point improvement (difference vs placebo: 32.0%; P = .005).

IN PRACTICE:

“In this phase 2 randomized clinical trial, ICP-332 was efficacious and demonstrated a favorable benefit-risk profile compared with placebo in adults with moderate-to-severe AD, supporting initiation of larger randomized, controlled, phase 3 studies to confirm its potential as an effective treatment for this population,” the study authors wrote.

SOURCE:

The study was led by Jinhua Xu, PhD, Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China, and was published online on January 14 in JAMA Dermatology.

LIMITATIONS:

The limitations included the small sample size and short treatment duration. Additionally, inclusion of only Asian patients could limit generalizability to other populations.

DISCLOSURES:

The study was funded by InnoCare Pharma Tech Co. Three authors reported being employed by InnoCare Pharma Tech Co., and one disclosed having a pending patent (PCT/CN2024/138717,63617161).

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.