ADvance-Asia Phase 3 Trial Monotherapy Cohort China Subgroup Results Show That Patients with Moderate-to-Severe Atopic Dermatitis Receiving Lebrikizumab Monotherapy for 16 Weeks Achieved Co-Primary Endpoints EASI-75 and IGA 0/1, Both Higher Than Placebo Group
In terms of itch severity, insomnia symptoms, and Dermatology Life Quality Index (DLQI), the Lebrikizumab group showed greater improvements than the placebo group
Safety profile consistent with prior global studies, with no new safety signals observed; all treatment-emergent adverse events were mild or moderate, with no serious adverse events or deaths reported
Disclaimer:
1. The drug and related indications described in this article have not been approved in mainland China.
2. Eli Lilly does not recommend the use of any unapproved drugs and/or unapproved indications.
ShanghaiJune 15, 2026 /PRNewswire/ — On June 13, 2026, Eli Lilly China presented results from the induction treatment period analysis of the China subgroup in the monotherapy (Mono) cohort of the ADvance-Asia (NCT06280716) Phase 3 registration trial for lebrikizumab at the 31st Annual Meeting of the Chinese Society of Dermatology (CSD).1 The ADvance-Asia study is a Phase 3 registration trial investigating the efficacy and safety of lebrikizumab in adult and adolescent (≥12 years) patients with moderate-to-severe atopic dermatitis in China and South Korea. The China subgroup results announced this time showed that in patients with moderate-to-severe atopic dermatitis, lebrikizumab achieved improvements in multiple efficacy endpoints, including skin clearance or near-clearance and itch relief, with a safety profile consistent with prior global studies.
Lebrikizumab is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity and slow dissociation rate.2,3,4 The cytokine IL-13 is a key pathogenic driver of atopic dermatitis, driving the cycle of type 2 skin inflammation, leading to skin barrier dysfunction, itching, skin thickening, and infection.5,6
The ADvance-Asia Phase 3 study China subgroup induction period data announced this time showed that compared with the placebo group, patients receiving lebrikizumab monotherapy for 16 weeks experienced greater improvements in skin inflammation signs, itch severity, insomnia symptoms, and quality of life, with overall benefits and safety consistent with results from prior global study populations.
Dr. Li Wang, Senior Vice President of Eli Lilly and Head of Lilly China Drug Development and Medical Affairs Center, stated, “Atopic dermatitis is one of the most common chronic inflammatory skin diseases. Despite the availability of various treatment options, there remain unmet clinical needs in terms of treatment convenience and long-term safety. We are very pleased to see that the ADvance-Asia China subgroup results are consistent with global studies, and this is the first Chinese population study result announced for lebrikizumab, reflecting its potential value in Chinese patients with atopic dermatitis.”
The key study data from the ADvance-Asia China subgroup announced this time include:
- The China subgroup included a total of 94 adult and adolescent patients with moderate-to-severe atopic dermatitis. For the primary endpoints, the lebrikizumab group showed higher EASI-75* response rates (64.1% vs 23.7%) and IGA 0/1** response rates (32.8% vs 10.4%) compared with the placebo group. During the 16-week induction treatment, the EASI-75 and IGA 0/1 response rates in the lebrikizumab group were consistently numerically higher than those in the placebo group at all time points, consistent with results from prior global study populations.
- For secondary endpoints, the lebrikizumab group showed greater improvements than the placebo group across multiple dimensions, including EASI-90† response rates, itch NRS‡ scores, insomnia scale scores, and DLQI§. In Chinese subjects, lebrikizumab monotherapy for 16 weeks achieved significant and clinically meaningful improvements in skin inflammation, itch severity, sleep impact, and quality of life, with results consistent with the global population.
- In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was similar between the lebrikizumab group and the placebo group. All TEAEs were mild or moderate, with no serious adverse events or deaths reported, and only one participant discontinued due to adverse events. The overall safety profile was consistent with prior global studies of lebrikizumab.
*EASI-75 = ≥75% reduction in Eczema Area and Severity Index from baseline; **IGA = Investigator’s Global Assessment score of 0 or 1 (“clear” or “almost clear”); †EASI-90 = ≥90% reduction in Eczema Area and Severity Index from baseline; ‡Numeric Rating Scale assessing itch severity from 0-10, with 10 representing the worst itch in the past 24 hours; §DLQI = Dermatology Life Quality Index.
CMAT-35794