Tralokinumab Maintains Efficacy in Hand AD Through 32 Weeks
KEY TAKEAWAYS
Tralokinumab met all efficacy and safety endpoints at weeks 16 and 32 in adults with moderate-to-severe AD with hand involvement.
The data showed improvements were sustained in itch, pain, and hand-specific severity outcomes.
- Researchers reported no new safety signals.
LEO Pharma has announced positive 32-week topline results from its ADHAND trial, a phase 3b study evaluating tralokinumab in adults with moderate-to-severe atopic dermatitis (AD) with hand involvement.
According to a press release from the manufacturer, the randomized, placebo-controlled study looked at tralokinumab 300 mg every two weeks as monotherapy in systemic-therapy-eligible patients. After 16 weeks of blinded treatment, participants began a 16-week open-label extension. At both 16 and 32 weeks, the trial met all primary and key secondary endpoints (clear or almost clear skin (IGA-AHE 0/1), as well as significant reductions in itch, pain, and improvements in sleep and quality of life). The data also showed that by week 16, 40.0% of patients on tralokinumab achieved IGA-AHE 0/1 compared to 10.6% in the placebo group. Symptom relief was improved as well, with 47.3% and 45.3% of treated patients achieving ≥4-point reductions in HESD itch and pain, respectively, vs 20.7% and 13.3% for placebo, respectively. Clinical gains were sustained through week 32.
No new safety signals were reported, including similar rates of conjunctivitis between treatment arms (3.8%).
“The hands are a hard-to-treat area and AD with hand involvement is often very burdensome for patients to live with" said Teodora Festini, Global Medical Affairs at LEO Pharma and presenting author at ISAD Congress 2025 in Melbourne, Australia, in the news release. "While the genitals and head-and-neck are also high burden areas, the hands are particularly susceptible to external triggers, which can make disease on the hands especially challenging to manage.”
Source: LEO Pharma press release. November 17, 2025.