Tralokinumab Update: Positive 16-Week Interim Results Reported for ADHAND Trial in Adults with Hand Eczema

Interim 16-week results from the phase 3b ADHAND trial show that tralokinumab significantly improves signs and symptoms of moderate-to-severe atopic dermatitis (AD) on the hands in adults eligible for systemic therapy. The trial met its primary and all key secondary endpoints, according to a statement from LEO Pharma, with statistically significant improvements over placebo and no new safety concerns reported.

Tralokinumab, a fully human monoclonal antibody that selectively targets interleukin (IL)-13, was administered at a dose of 300 mg every 2 weeks as monotherapy. By week 16, a significantly greater proportion of participants receiving tralokinumab achieved an Investigator’s Global Assessment for atopic dermatitis on the hands (IGA-AHE) score of 0 or 1 compared to placebo, LEO Pharma reported. Additional endpoints met included 4-point or greater reductions in itch and pain scores on the Hand Eczema Symptom Diary (HESD) and 75% or greater and 90% or greater improvement on the Hand Eczema Severity Index (HECSI).

“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,” Jacob Pontoppidan Thyssen, MD, PhD, chief scientific officer and executive vice president at LEO Pharma, said in a statement. “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.”

Adverse events associated with tralokinumab were mostly non-serious and mild to moderate in severity, with no new safety signals observed. All patients in the trial will now enter an open-label extension phase in which tralokinumab will be administered biweekly through week 32. LEO Pharma expects to report final 32-week results of ADHAND by the end of 2025.

"Living with atopic dermatitis 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,” Benjamin Ehst, MD, PhD, investigator and chief medical officer at Oregon Medical Research Center, said.

More than 50% of individuals with moderate-to-severe atopic dermatitis are affected on the hands, with many experiencing extensive body surface area involvement.1 Lifetime prevalence of the phenotype is approximately 15% and in up to two-thirds of affected individuals, the disease becomes chronic. The impact on quality of everyday life is well recognized and includes impairment of physical functioning, often related to visible lesions, severe pruritis, and painful fissures. Moderate-to-severe disease affects up to one-third of people with atopic dermatitis of the hands.2

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. July 9, 2025. Accessed July 10, 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. Weidinger S, Novak N. Hand eczema. Lancet. 2024;404(1047):2476-2486. doi:10.1016/S0140-6736(24)01810-5