LEO Pharma Announces Positive Topline 32-Week Key Results in ADHAND Trial

BALLERUP, Denmark, November 17, 2025 – LEO Pharma A/S, a global leader in medical dermatology, today announced positive topline key results from the 32-week analysis of the Phase 3b ADHAND trial evaluating tralokinumab for the treatment of adult patients with  atopic dermatitis with moderate-to-severe hand involvement, who are candidates for systemic therapy.

ADHAND is a phase 3b, interventional, adaptive, placebo-controlled clinical trial evaluating the efficacy and safety of tralokinumab 300 mg administered every two weeks as a monotherapy compared with placebo in patients living with moderate-to-severe atopic dermatitis on the hands who are candidates for systemic therapy.¹ After the first 16 weeks double-blinded treatment period, all patients received open-label, 300 mg tralokinumab every 2 weeks for 16 weeks.

The trial met all key primary and secondary endpoints at Week 16 as well as all endpoints at Week 32, including efficacy on extent and severity of disease, itch, pain, sleep, and health-related quality of life and the safety and tolerability of continued tralokinumab treatment.

“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.”

Detailed results of this Week 32 analysis will be submitted for scientific presentation and publication at a later date.

Positive 16-week data presented at ISAD 2025

Tralokinumab showed statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch and pain at Week 16 in ADHAND.³

“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.”

The data showed an early onset of effect observed from week 2 in the primary endpoint. There was a statistically significant difference in the proportion of patients who achieved an Investigator’s Global Assessment for Atopic Hand Eczema (IGA-AHE) score of 0/1 – clear or almost clear skin on the hands at Week 16 (40.0% of patients (N=156) compared with 10.6% for placebo (N=79)).³

At Week 16, tralokinumab also achieved a statistically significant reduction in both itch and pain versus placebo; 47.3% of tralokinumab treated patients achieved a ≥4point reduction in HESD itch versus 20.7% with placebo, and 45.3% achieved a ≥4point reduction in HESD pain versus 13.3% with placebo, indicating meaningful improvement in these key symptoms.³

Furthermore, 41.7% of tralokinumab treated patients achieved HECSI90 versus 10.9% with placebo, a difference of 30.8 percentage points, indicating a substantial and clinically meaningful improvement at Week 16.³

Tralokinumab was generally well tolerated with no new safety signals identified, continuing the known overall safety profile of the treatment. The majority of adverse events observed were non-serious, mild or moderate in severity – and the number of adverse events is consistent between tralokinumab (60.3%) and placebo (60.8%). Similarly, when considering adverse events of special interest, the number of patients suffering from conjunctivitis is on par between the tralokinumab arm (3.8%) and the placebo arm (3.8%).³

The positive Week 16 data was presented at the 15th Georg Rajka International Symposium on Atopic Dermatitis (ISAD), held from October 24 – 26, 2025, in Melbourne, Australia.³

For more information on the trial (NCT05958407) go to clinicaltrials.gov.

*ENDS*

About the ADHAND Trial

The ADHAND trial (NCT05958407) is a Phase 3b, randomized, double-blind, placebo-controlled, interventional, adaptive clinical study designed to evaluate the efficacy and safety of tralokinumab 300 mg administered every two weeks as a monotherapy in adult patients with moderate-to-severe atopic dermatitis on the hands who are candidates for systemic therapy followed by a 16-week, open-label treatment period. Patients were randomized to receive either tralokinumab or placebo.¹

The objective of the open label treatment period up to 32 weeks is to evaluate the efficacy on extent and severity of the disease, itch, pain, sleep, health-related quality of life and the safety and tolerability of continued tralokinumab treatment in subjects with moderate-to-severe atopic hand eczema.¹

Secondary endpoints at Week 32 include the proportion of patients achieving an Investigator’s Global Assessment for atopic dermatitis on the hands (IGA-AHE) score of 0 or 1, as well as reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 32 and as at least 75% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 32.¹

The safety endpoint of the trial is the number of treatment-emergent adverse events.¹

The study concludes at Week 32, followed by a safety follow-up period from Week 32 to Week 36.¹

About Atopic Dermatitis on the Hands

Atopic dermatitis on the hands is a disabling skin condition that can strongly impact the quality of life and occupational performance of affected individuals.² In a study by Silverberg et al (2023), more than 50% of patients with moderate-to-severe atopic dermatitis have atopic dermatitis on the hands; of these, almost 60% have high body surface area affected, defined as 10% BSA or higher.⁶ Hands are considered a common and burdensome area of the disease.⁶ Lesions are often located on the wrists and backs of the hands, areas frequently exposed to environmental triggers.⁷

About Adtralza^® (tralokinumab) / Adbry ^® (tralokinumab-ldrm)  

Adtralza^® (tralokinumab), which is marketed under the tradename Adbry^® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^4,5

Adtralza^® / Adbry^® is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy in the European Union, United States, Canada, the United Arab Emirates and South Korea. Adtralza^® is approved for use in adults with moderate to severe atopic dermatitis in Switzerland, Saudi Arabia and Japan.

References

1. 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.
2. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
3. Ehst B, et al. “Tralokinumab is effective and well-tolerated in adults with atopic dermatitis with moderate-to-severe hand involvement who are candidates for systemic therapy: Week 16 results from the phase 3b ADHAND trial”. Presented at Georg Rajka International Symposium on Atopic Dermatitis (ISAD) Annual Meeting, Melbourne, Australia October 24 – 26 2025.
4. Adtralza^® (tralokinumab). Summary of Product Characteristics. LEO Pharma. November 2025
5. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
6. 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.
7. Halling-Overgaard AS, et al. Dermatol Clin. 2017;35(3):365-372.

MAT-87899 November 2025