LEO Pharma initiates phase 2a trial of delgocitinib cream for rare skin condition

Ella Day | June 3, 2025 | News story | Research and Development |  Dermatology, LEO Pharma, Skin, clinical trial, delgocitinib cream, rare skin condition 

LEO Pharma has initiated a phase 2a trial investigating delgocitinib cream in adults with mild-to-severe palmoplantar pustulosis (PPP). The DELTA NEXT study will analyse the efficacy and safety of the therapy compared with cream vehicle across sites in the US, UK, Germany, Poland and Canada.

PPP is a chronic, relapsing inflammatory skin condition characterised by sterile pustules, erythema, and scaling on the palms and soles. The condition has a high symptom burden, often resulting in pain, fatigue and impaired mobility. Treatment options remain limited, and there are currently no approved systemic therapies for PPP in the US or Europe.

Delgocitinib cream inhibits the activity of all four janus kinases, key mediators in inflammatory signalling pathways. The compound has already been approved in several markets for the treatment of chronic hand eczema, and the DELTA NEXT trial marks its first investigation in PPP.

“Despite the significant burden it places on patients, treatment options remain limited,” said Robert Bissonnette, international coordinating investigator. “There is a real and urgent need for effective therapies.”

The trial plans to recruit up to 135 patients of whom topical corticosteroids are inadequate or inadvisable. Recruitment will take place across 40 to 45 clinical sites.

Ella Day

3/6/25