LEO Pharma Launches Study of Delgocitinib for PPP
Key Takeaways
LEO Pharma announced the launch of the DELTA NEXT study of delgocitinib cream in adults with palmoplantar pustulosis (PPP).
Delgocitinib is a topical pan-JAK inhibitor approved for chronic hand eczema.
PPP is an uncommon, relapsing inflammatory condition with no currently approved systemic therapies.
LEO Pharma announced today the initiation of a phase 2a trial looking at the safety and efficacy of delgocitinib cream in adults with palmoplantar pustulosis (PPP).
According to a news release from the manufacturer, the DELTA NEXT proof-of-concept study will enroll up to 135 adult patients with mild to severe PPP at 40 to 45 sites across the U.S., Canada, the United Kingdom, Germany, and Poland. The manufacturer said the trial is designed to compare delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, with a vehicle cream in patients for whom topical corticosteroids are inadequate.
The launch represents the first disease targeted by LEO Pharma for delgocitinib cream since completing its phase 3 DELTA program in chronic hand eczema.
“PPP is a disease with few treatment options that can severely affect quality of life,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma. “We are hopeful that this therapy could potentially provide much-needed help for patients suffering from this devastating condition.”
The news release also noted that there are no advanced systemic treatments currently approved for PPP in the U.S. or Europe. Delgocitinib cream, currently under regulatory review in the U.S., is approved in the EU, UK, Switzerland, and UAE for adults with moderate to severe chronic hand eczema where corticosteroids are unsuitable.
“I’ve seen firsthand how PPP can severely disrupt patients’ lives, making it painful to walk, perform activities of daily living and impacting their ability to work,” said Dr. Robert Bissonnette, the international coordinating investigator (ICI) on the DELTA NEXT trial and Chairman at Innovaderm Montreal, Canada, in the press release. “Despite the significant burden it places on patients, treatment options remain limited. There is a real and urgent need for effective therapies."
Source: LEO Pharma press release. June 3, 2025.