LEO Pharma announced positive results from a 16-week interim analysis of the phase 3b ADHAND trial evaluating tralokinumab for the treatment of moderate to severe atopic dermatitis (AD) on the hands in adults who are candidates for systemic therapy. The fully human biologic met all key primary and secondary endpoints, showing statistically significant results compared to placebo.
Addressing a High-Burden Treatment Area
Tralokinumab works by selectively targeting the interleukin-13 (IL-13) cytokine, which plays a central role in the pathophysiology of atopic dermatitis. While tralokinumab has previously demonstrated efficacy in generalized moderate to severe AD, this study addresses its potential benefit in patients with disease concentrated in high-burden, difficult-to-treat areas such as the hands.
"Living with AD can be bad enough, but having one's hands involved can add to the discomfort and disability that can occur when simply trying to function each day," said Benjamin Ehst, MD, PhD, dermatologist, investigator, co-owner and CMO at Oregon Medical Research Center, Portland. "From my interactions with LEO Pharma, they are deeply committed to addressing the unmet needs in challenging dermatological conditions and they recognize the profound impact that skin diseases of the hands can have on patients' quality of life."
Trial Design and Methodology
ADHAND (NCT05958407) is a phase 3b, interventional, adaptive, placebo-controlled clinical trial evaluating the efficacy and safety of tralokinumab 300mg given every 2 weeks as a monotherapy compared with placebo. The interim analysis assessed treatment outcomes at week 16, capturing the results of the primary and key secondary endpoints. The final results of the entire 32-week trial are expected by the end of the year.
The primary endpoint of the ADHAND trial is the proportion of patients achieving an Investigator's Global Assessment for atopic dermatitis on the hands (IGA-AHE) score of 0 or 1 at Week 16. Key secondary endpoints at Week 16 include reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.
Positive Efficacy and Safety Results
According to LEO Pharma's press release, the interim results met the primary endpoint and all secondary endpoints. A statistically significant proportion of patients achieved an IGA-AHE score of 0 (clear) or 1 (almost clear) at Week 16 compared to placebo. Secondary endpoints also showed favorable outcomes, including meaningful reductions in itch and pain scores and improvements of at least 75% and 90% from baseline on the Hand Eczema Severity Index (HECSI).
Researchers noted the treatment was generally well-tolerated, with no new safety signals identified. They stated the majority of adverse events observed were "non-serious, mild, or moderate in severity." All of the signs and symptoms of AD on the hands were improved significantly early in the tralokinumab treatment period compared to placebo.
Significant Unmet Medical Need
Atopic dermatitis on the hands is a disabling skin condition that can strongly impact the quality of life and occupational performance of affected individuals. In a study by Silverberg et al (2023), more than 50% of patients with moderate-to-severe atopic dermatitis have atopic dermatitis on the hands; of these, almost 60% have high body surface area affected, defined as 10% BSA or higher.
"These interim results mark an important step forward in addressing the needs of patients with moderate to severe atopic dermatitis that affects high-burden and hard-to-treat areas such as the hands despite available treatments," said Jacob Pontoppidan Thyssen, PhD, chief scientific officer & executive vice president, science, search & innovation at LEO Pharma. "I am particularly excited about the success of the adaptive trial design, which has enabled us to generate meaningful data more rapidly and accelerate our journey towards helping patients with this debilitating disease."
Next Steps
Following the first 16 weeks of the trial, all patients will move to the 16-week open-label treatment period. During this time, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. While the interim findings are promising, peer-reviewed publication and additional data from the open-label extension will be needed to fully understand the long-term efficacy and safety profile of tralokinumab in this patient subgroup.
Detailed results of this interim analysis will be submitted for scientific presentation and publication at a later date.
