Tralokinumab Shows Hand Relief in ADHAND Trial

Image Credit: © DermNet

Today, 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. According to a news release from the company, the results of the fully human biologic met all key primary and secondary endpoints, showing “statistically significant” results compared to placebo.¹

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. These patients often experience impaired quality of life and limited therapeutic options.

"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, in the release. “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."

Methods

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, which assessed treatment outcomes at week 16, captured the results of the primary and key secondary endpoints. The final resultsof the entire 32 week trial are expected by the end of the year.²

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 Investigator’s Global Assessment for Atopic Dermatitis on the Hands (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—as measured by the Hand Eczema Symptom Diary (HESD)—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.” They noted all of the signs and symptoms of AD on the hands were improved significantly early in the tralokinumab treatment period compared to placebo.

“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, in the release. “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.”

Conclusion

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.

References

1. LEO Pharma announces positive 16-week interim results for ADHAND trial for tralokinumab in patients with moderate to severe atopic dermatitis on the hands who are candidates for systemic therapy. News Release. LEO Pharma. Published July 9, 2025. Accessed July 9, 2025. https://www.businesswire.com/news/home/20250709476764/en/LEO-Pharma-Announces-Positive-16-Week-Interim-Results-for-ADHAND-Trial-for-Tralokinumab-in-Patients-with-Moderate-to-Severe-Atopic-Dermatitis-on-the-Hands-who-are-Candidates-for-Systemic-Therapy
2. ClinicalTrials.gov. National Library of Medicine (U.S.). A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate to severe atopic dermatitis on the hands Who Are Candidates for Systemic Therapy (ADHAND). Identifier: NCT05958407. https://clinicaltrials.gov/study/NCT05958407.