Tralokinumab (Adbry/Adtralza, LEO Pharma) met the primary and all key secondary endpoints in an interim analysis of a Phase 3b study of adults with moderate-to-severe atopic dermatitis (AD), the Company reports.
ADHAND is a Phase 3b clinical trial that evaluated the efficacy and safety of tralokinumab 300mg administered every two weeks as a monotherapy compared with placebo in patients living with moderate-to-severe AD on the hands who are candidates for systemic therapy.
The primary endpoint of the ADHAND trial is the proportion of patients achieving an Investigator’s Global Assessment for AD 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.
The trial met the primary endpoint and all secondary endpoints, demonstrating a statistically significant improvement in atopic dermatitis on the hands after 16 weeks of treatment compared to the 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 AD on the hands were improved significantly early in the treatment period with tralokinumab compared to placebo.
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. 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.
“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,” says Benjamin Ehst, MD, PhD, Dermatologist, Investigator, Co-Owner, and CMO at Oregon Medical Research Center in Portland, OR, in a news release. “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.
Adtralza (tralokinumab is marketed under the tradename Adbry in the U.S. Tralokinumab is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older in the European Union, United States, Canada, the United Arab Emirates, and South Korea. It is approved for use in adults with moderate to severe AD in Switzerland, Saudi Arabia, and Japan.
