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

BALLERUP, Denmark, July 9, 2025 – LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results from a 16-week interim analysis of the Phase 3b ADHAND trial evaluating tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis on the hands, who are candidates for systemic therapy.

Tralokinumab is a fully human biologic that selectively targets the IL-13 cytokine, the key driver of atopic dermatitis signs and symptoms.^2,3

ADHAND is a phase 3b, interventional, adaptive, placebo-controlled clinical trial that evaluated 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. This interim analysis assessed treatment outcomes at Week 16, thereby capturing the results of the primary endpoint and key secondary endpoints. The trial will continue through Week 32, with final results expected by the end of the year.¹

The trial met the primary endpoint and all secondary endpoints with a statistically significant improvement in atopic dermatitis on the hands after 16 weeks of treatment compared to placebo. The treatment was also generally well-tolerated, with no new safety signals identified. The majority of adverse events observed were non-serious, mild or moderate in severity. All of the signs and symptoms of atopic dermatitis on the hands were improved significantly early in the treatment period with tralokinumab compared 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,” said Dr Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. “I am particularly excited about the success of the adaptive trial design, which has enabled us to generate meaningful data more rapidly and accelerate our journey towards helping patients with this debilitating disease.”

"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,” said Benjamin Ehst, MD, PhD, Dermatologist, Investigator, Co-Owner and CMO at Oregon Medical Research Center, Portland. “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."

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

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

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. Patients were randomized to receive either tralokinumab or placebo.¹

The primary endpoint of the ADHAND trial is the proportion of patients achieving an Investigator’s Global Assessment for atopic dermatitis on the hands (IGA-AHE) score of 0 or 1 at Week 16. Key secondary endpoints at Week 16 include reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 was the key safety endpoint of the trial.¹

Following the first 16 weeks of the trial, all patients will move to the 16-week open-label treatment period. During this time, all trial participants will receive tralokinumab injections every two weeks for 16 weeks.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.⁴ 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.⁵

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.^2,3

Adtralza^® / Adbry^® is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older 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.

 

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

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. Adtralza^® (tralokinumab). Summary of Product Characteristics. LEO Pharma. May 2025
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
4. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
5. 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.

MAT-83883 July 2025