Tralokinumab Shows Durable Efficacy and Safety Through 32 Weeks in Phase 3b ADHAND Trial

Last week, LEO Pharma announced positive topline findings from the 32-week analysis of the phase 3b ADHAND trial, providing new evidence supporting the efficacy and safety of tralokinumab (Adbry) for adults with atopic dermatitis (AD) involving the hands.¹

“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,” said Christophe Bourdon, Chief Executive Officer at LEO Pharma. “These results build on the impressive 16-week data, reaffirming 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 for patients. Seeing such positive outcomes in these visible, high burden areas gives us a brighter outlook on what we can achieve for those living with this challenging condition.”¹

Study Design and Methods

ADHAND (NCT05958407) is a randomized, double-blind, placebo-controlled, adaptive phase 3b trial evaluating tralokinumab 300 mg administered every 2 weeks as a monotherapy in adults with moderate-to-severe AD on the hands who are candidates for systemic therapy. The initial 16-week blinded period was followed by a 16-week open-label phase in which all participants received tralokinumab. Endpoints included clinician-assessed disease severity using the Investigator’s Global Assessment for Atopic Hand Eczema (IGA-AHE) and the Hand Eczema Severity Index (HECSI), as well as patient-reported symptoms of itch, pain, sleep disturbance, and quality of life. Safety outcomes included treatment-emergent adverse events and adverse events of special interest through week 32.

Efficacy Outcomes

The week 32 topline results build on the positive outcomes reported at week 16, demonstrating durable clinical benefit after transition to open-label treatment.² According to LEO Pharma, all key primary and secondary endpoints at week 16 and all endpoints assessed at week 32 were met. Although detailed 32-week numerical outcomes have not yet been released, the company reports consistent improvement across disease extent and severity, itch and pain reduction, sleep outcomes, and health-related quality of life.

The 16-week blinded period results, which were presented at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD) in Melbourne, Australia, showed early and robust treatment effects. By week 16, 40.0% of patients on tralokinumab achieved IGA-AHE 0/1 (clear or almost clear skin on the hands), compared with 10.6% in the placebo arm. Symptom improvement was similarly pronounced: 47.3% of tralokinumab-treated participants achieved at least a 4-point reduction in HESD itch compared with 20.7% on placebo, and 45.3% achieved a ≥4-point reduction in HESD pain compared with 13.3% on placebo. Tralokinumab also produced substantial improvement in hand eczema severity, with 41.7% reaching HECSI90 versus 10.9% on placebo. Investigators reported early onset of effect as early as week 2.

Safety Outcomes

Tralokinumab continued to show a favorable safety and tolerability profile through both phases of the study. During the 16-week randomized period, adverse event rates were comparable between the tralokinumab (60.3%) and placebo (60.8%) groups. Most events were non-serious and mild or moderate in severity. Rates of conjunctivitis were balanced in both treatment arms at 3.8%. No new safety signals have been identified through week 32, which is consistent with the established profile of tralokinumab in AD.

Final Thoughts

Tralokinumab is a fully human monoclonal antibody that selectively neutralizes IL-13, a key cytokine implicated in the pathophysiology of AD. The drug is approved for moderate-to-severe AD in adults and adolescents ≥12 years in multiple global markets. LEO Pharma stated that full 32-week data will be submitted for scientific presentation and peer-reviewed publication.

“The hands are a hard-to-treat area and atopic dermatitis with hand involvement is often very burdensome for patients to live with. 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,” says Teodora Festini, Global Medical Affairs at LEO Pharma and presenting author at ISAD Congress 2025 in Melbourne, Australia. “The detailed 16-week results and now these high-level findings from week 32 underscores LEO Pharma's commitment to making a difference for patients with atopic dermatitis - particularly where their disease is hard to treat.”¹

References

1. LEO Pharma Announces Positive Topline 32-Week Key Results in ADHAND Trial. News release. LEO Pharma. Published November 17, 2025. Accessed November 25, 2025. https://www.leo-pharma.com/media-center/news/2025-adhand-32w

2. 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 November 25, 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