Tralokinumab Looks Promising to Treat Hand Involvement in Atopic Dermatitis

LEO Pharma has reported new 32-week topline results from the phase 3b ADHAND trial, reinforcing earlier findings that tralokinumab, an interleukin (IL)-13 inhibitor, may meaningfully benefit adults with moderate-to-severe atopic dermatitis (AD) involving the hands—a population with high symptom burden and limited treatment options.¹

Hand involvement affects more than 50% of individuals with moderate-to-severe disease, and nearly 60% of those have an affected body survace area (BSA) of 10% or greater. Lesions frequently involve the wrists and backs of the hands, areas continually exposed to environmental triggers, intensifying both physical and functional impact.²

For the ADHAND study, researchers randomly assigned participants to tralokinumab 300 mg every 2 or placebo for 16 weeks, followed by a 16-week open-label extension. At Week 16, 40.0% of participants treated with tralokinumab (n = 156) achieved an Investigator’s Global Assessment for Atopic Hand Eczema (IGA-AHE) (IGA-AHE) score of 0/1—clear or almost clear skin—compared with 10.6% of those on placebo (n = 79).

Tralokinumab-treated participants also reported significant symptom relief: 47.3% achieved a 4 point or greater reduction in itch vs half that proportion (20.7%) of placebo-treated participants, and 45.3% achieved a the same reduction in pain, compared with 13.3% of participants in the placebo group. Hand Eczema Severity Index scores of 90%or greater (HESI-90) were documented for 41.7% vs 10.9%, a 30.8-point difference.

Effects began early, with improvements noted by week 2, according to Leo Pharma. The results were sustained at week 32, when all participants had received tralokinumab.

Tralokinumab’s safety profile remained consistent through 32 weeks, the company said. Adverse events occurred in 60.3% of participants on tralokinumab and 60.8% on placebo and most were categorized as mild or moderate. Conjunctivitis occurred in 3.8% of patients in both arms. No new safety signals emerged.

“We are truly excited about these 32-week key results, which bring new hope for patients suffering from atopic dermatitis with moderate-to-severe hand involvement,” Christophe Bourdon, LEO Pharma CEO, said in a statement. The findings, which expand on earlier 16-week data, reaffimr "our confidence in how tralokinumab can make a difference for patients living with this debilitating disease. Hand involvement is not only physically painful and functionally limiting, but it can also be emotionally burdensome," Bourdon continued.

"While the genitals and head-and-neck are also high burden areas, the hands are particularly susceptible to external triggers," making the disease particularly challenging to manage, Teodora Festini, from LEO Pharma Global Medical Affairs who presented tralokinumab outcomes at the ISAD Congress 2025 in Melbourne, Australia.

Tralokinumab is a high-affinity fully human monoclonal antibody (mAb) developed to bind to and inhibit the IL-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.³

The mAb is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescents 12 years and older who are candidates for systemic therapy in the US.

LEO Pharma said it plans to submit the full week 32 ADHAND data for scientific review and publication.

1. LEO Pharma Announces Positive Topline 32-Week Key Results in ADHAND Trial. News release. LEO Pharma. November 17, 2025. Accessed November 17, 2025. https://aijourn.com/leo-pharma-announces-positive-topline-32-week-key-results-in-adhand-trial/
2. Silverberg JI, Simpson B, Abuabara K, et al. Prevalence and burden of atopic dermatitis involving the head, neck, face, and hand: A cross sectional study from the TARGET-DERM AD cohort. J Am Acad Dermatol. 2023;89(3):519-528.
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.