Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

LEO Pharma A/S has announced positive topline key findings on tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement who are also candidates for systemic treatments.1

The November 17 announcement released by LEO Pharma was the result of a 32-week analysis of the phase 3b ADHAND trial (NCT05958407), evaluating patients with atopic dermatitis and disease involvement affecting the hands.2 Atopic dermatitis on the hands is a disabling skin disease known to impact patients' quality of life and occupational performance significantly.

“The hands are a hard-to-treat area and atopic dermatitis with hand involvement is often very burdensome for patients to live with," presenting author Teodora Festini, of Global Medical Affairs at LEO Pharma, said in a statement.1 "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."

In an analysis highlighted in the company's release, over half of individuals with moderate-to-severe atopic dermatitis were shown to have atopic dermatitis on the hands. Among these individuals, close to 60% were shown to have high body surface area impacted by atopic dermatitis, defined as 10% body surface area (BSA) or higher.3

Tralokinumab, which is marketed under the tradename Adbry within the US, was designed as a high-affinity fully human monoclonal antibody. It binds to and inhibits the interleukin (IL)-13 cytokine, a cytokine which plays a notable role in the immune and inflammatory processes underlying atopic dermatitis. To assess a 300 mg dosing regimen of tralokinumab, the ADHAND study was conducted.

ADHAND is phase 3b, interventional, adaptive, placebo-controlled clinical study assessing tralokinumab administered every 2 weeks as a monotherapy, comparing the drug with placebo in subjects living with moderate-to-severe atopic dermatitis on the hands who are also candidates for systemic drugs. Following the initial 16 weeks double-blinded treatment period, all of those involved as participants were given open-label, 300 mg tralokinumab every 2 weeks for a total of 16 weeks.

The aim of the open label treatment period up to 32 weeks is to assess the medication's efficacy on extent and severity of the disease, pain, pruritus, sleep, and health-related quality of life. The investigative team also sought to explore tralokinumab's safety and tolerability with continued use. Secondary endpoints at the 32-week mark include the proportion of subjects attaining an Investigator’s Global Assessment for atopic dermatitis on the hands (IGA-AHE) score of 0 or 1.

Additionally, the team looked at other endpoints such as reductions of participants' itch and pain scores of ≥4 points assessed by the Hand Eczema Symptom Diary (HESD) from baseline to the 32-week mark and at least 75% improvement from the point of baseline on Hand Eczema Severity Index (HECSI) scores at the 32-week mark. The safety endpoint of the trial is the number of treatment-emergent adverse events.

The study concludes at the 32-week mark, followed by a safety follow-up period from Week 32 - Week 36. The analysis was shown to have met all key primary and secondary endpoints at the 16-week mark, as well as all endpoints at 32 weeks. Detailed results of this Week 32 analysis will be submitted for scientific presentation and publication on a later date.

Overall, tralokinumab therapy showed statistically significant improvements compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch and pain at Week 16 in the ADHAND study.1 Investigators noted an early onset of effect observed from the 2-week mark in the study's primary endpoint.

A statistically significant difference was also observed by the investigators in the proportion of trial subjects who attaining an IGA-AHE score of 0/1 – clear or almost clear skin on the hands at Week 16 (40.0% of subjects (N=156) as opposed to 10.6% for placebo (N=79)). Tralokinumab was also shown to have achieved a statistically significant reduction at Week 16 in both pruritus and pain versus placebo, with 47.3% of tralokinumab treated individuals showing a ≥4 point HESD itch reduction versus 20.7% on placebo, and 45.3% attaining a ≥4 point reduction in HESD pain versus 13.3% on placebo.

These findings suggest tralokinumab use led to meaningful improvement in these key disease symptoms. Additionally, the ADHAND investigators found 41.7% of those in the tralokinumab cohort attained HECSI90 as opposed 10.9% in the placebo cohort. This difference of 30.8 percentage points would suggest a substantial and clinically meaningful disease improvement at the 16-week mark.

The drug was generally found to be well tolerated, with no new safety signals being observed. This aligns with the known overall safety profile of tralokinumab. The majority of adverse events observed were shown to be non-serious, mild or moderate in severity, and consistent between tralokinumab (60.3%) and placebo (60.8%).

These positive Week 16 findings were presented at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD), held from October 24 – 26, 2025, in Melbourne, Australia.

References

1. LEO Pharma Announces Positive Topline 32-Week Key Results in ADHAND Trial. LEO Pharma. November 17, 2025. https://www.leo-pharma.com/media-center/news/2025-adhand-32w.

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 dematitis on the hands Who Are Candidates for Systemic Therapy (ADHAND). Identifier: NCT05958407. https://clinicaltrials.gov/study/NCT05958407.

3. 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.