Positive 16-Week Findings Highlighted on Tralokinumab for Atopic Dermatitis on the Hands

Tralokinumab (Adbry) use among individuals with atopic dermatitis impacting the hands may lead to significant disease improvements within 16 weeks, recent findings suggest, as well as being well-tolerated among patients.1

These findings were released in a July 9 announcement by LEO Pharma A/S, highlighting the phase 3b ADHAND trial’s results among those with atopic dermatitis on the hands who are also candidates for systemic therapy. Atopic dermatitis on the hands has a notable impact on quality of life and work performance among those affected, and one prior study identified 50% of patients with moderate-to-severe atopic dermatitis reporting disease impact on the hands.2

"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, dermatologist, investigator, and CMO at Oregon Medical Research Center, said in a statement.1 “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."

The phase 3b ADHAND analysis looked at tralokinumab in moderate-to-severe atopic dermatitis impacting the hands. The drug itself was designed as a fully human biologic that can selectively target the interleukin (IL)-13 cytokine, a known driver of atopic dermatitis signs as well as symptoms.

The ADHAND study (NCT05958407) was designed as a phase 3b, adaptive, placebo-controlled interventional clinical study that would assess the effectiveness and safety of tralokinumab. During the analysis, the drug was administered at a dose of 300 mg every 2 weeks, as a standalone treatment for those with moderate-to-severe disease affecting the hands who were known to be eligible for systemics.

Those taking part in the analysis were randomly assigned to receive either tralokinumab or a placebo. The ADHAND study's primary aim was to determine the proportion of subjects who attained a score of 0 (clear) or 1 (almost clear) on the Investigator’s Global Assessment for Atopic Dermatitis on the Hands (IGA-AHE) at the 16-week mark. In terms of key secondary endpoints, the investigators at the same timepoint looked at subjects who attained a ≥4-point reduction in their itch and pain scores as recorded in the Hand Eczema Symptom Diary (HESD).

Additionally, the ADHAND team looked at who showed disease improvements of at least 75% (HECSI-75) and at least a 90% improvement (HECSI-90) from baseline on the Hand Eczema Severity Index (HECSI). They assessed safety through the tracking of the number of treatment-emergent adverse events (TEAEs) noted between baseline and the 16-week mark.

This interim analysis presents efficacy and safety findings through the 16-week mark, though the trial remains ongoing and will continue to collect data through Week 32. The final results are anticipated later in the year.Following the participants' completion of the initial 16-week treatment phase, all of those taking part are set to enter a 16-week open-label extension, during which every one of these individuals will receive tralokinumab on a bi-weekly basis.

Overall, at Week 16, tralokinumab was shown to lead to statistically significant benefits across the primary and all secondary endpoints when compared with the placebo arm of the ADHAND study.1 These data would suggest a meaningful reduction in hand-specific atopic dermatitis signs and symptoms. The therapy was generally well-tolerated, with no new safety concerns being identified by the investigators.

The investigative team concluded that most of the identified adverse events had been non-serious and classified as mild or moderate in their level of intensity. Notably, the team identified improvements in clinical signs and patient-reported symptoms early in the treatment course with tralokinumab relative 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,” Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President of Science, Search & Innovation at LEO Pharma, said in a statement.1

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. LEO Pharma. 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. 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. Accessed July 9, 2025.