June 3, 2025 —LEO Pharma A/S, a global leader in medical dermatology, announced today the start of the DELTA NEXT phase 2a trial. This proof-of-concept study will test the safety and effectiveness of delgocitinib cream against a placebo cream in adults with mild to severe Palmoplantar Pustulosis (PPP).
PPP is the first new condition for which LEO Pharma will study delgocitinib cream since completing the Phase 3 DELTA trials for Chronic Hand Eczema (CHE).
Christophe Bourdon, CEO of LEO Pharma, said, “The DELTA NEXT trial marks an important step in developing delgocitinib cream. PPP is a disease with very limited treatment options that greatly affects patients’ quality of life. We hope this treatment can offer relief to those suffering from this challenging condition.”
Palmoplantar Pustulosis is a rare, chronic skin disease marked by repeated outbreaks of sterile pustules, redness, blisters, and scaling on the palms and soles. It causes significant pain and fatigue and often disrupts daily activities. Common triggers include smoking, infections, and stress. The disease is also linked to other health issues such as thyroid problems and metabolic syndrome.
Currently, no advanced systemic treatments for PPP are approved in the U.S. or Europe. The complex immune responses in PPP may explain why many targeted biologic treatments have not been effective in clinical trials.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor that blocks the activity of all four JAK enzymes involved in inflammation. This trial aims to see if inhibiting multiple JAKs can better control PPP symptoms.
Dr. Robert Bissonnette, international coordinating investigator on the DELTA NEXT trial and Chairman at Innovaderm in Montreal, Canada, stated, “I have witnessed how PPP severely disrupts patients’ lives, making walking painful and daily tasks difficult. Despite this heavy burden, treatment options are very limited. There is an urgent need for effective therapies.”
The trial will enroll up to 135 adults with active, chronic, mild to severe PPP who have not responded well to topical corticosteroids or for whom such treatment is unsuitable. Patients will be recruited from 40 to 45 sites across the United States, Canada, the United Kingdom, Germany, and Poland.
Delgocitinib cream is already approved in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for moderate to severe chronic hand eczema in adults who cannot use topical corticosteroids. The drug is also under regulatory review in other countries, including the United States.
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