Positive Early Results in Tralokinumab Trial for AD on Hands

A trial evaluating tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) on the hands, who are candidates for systemic therapy, met the primary endpoint and all secondary endpoints with a statistically significant improvement in AD on the hands after 16 weeks of treatment compared to placebo, LEO Pharma A/S announced.

The positive results were from a 16-week interim analysis of the Phase 3b ADHAND trial—a phase 3b, interventional, adaptive, placebo-controlled clinical trial that evaluated the efficacy and safety of tralokinumab 300 mg administered every 2 weeks as a monotherapy compared with 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.

“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 Jacob Pontoppidan Thyssen, MD, PhD, DmSci, 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.”

In addition to the primary and secondary endpoints, the treatment was 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.

"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 investigator Benjamin Ehst, MD, PhD, co-owner and CMO at Oregon Medical Research Center in 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."