PPP is the first disease for which LEO Pharma will investigate delgocitinib cream since completion of the Phase 3 DELTA trials in Chronic Hand Eczema (CHE).

“The DELTA NEXT trial in PPP represents an exciting new chapter in the clinical development journey of delgocitinib cream,” says Christophe Bourdon, Chief Executive Officer, LEO Pharma. “PPP is a disease with few treatment options that can severely affect quality of life. We are hopeful that this therapy could potentially provide much-needed help for patients suffering from this devastating condition.”

About PPP

PPP is an uncommon, chronic, inflammatory, relapsing skin disease characterized by repeated episodes of sterile pustules alongside erythema, blistering and scaly skin on the palms and/or soles of the feet. Patients often experience pain, fatigue, and the condition can be triggered by factors such as smoking, infections, and stress. PPP is associated with comorbidities such as thyroid dysfunction and metabolic syndrome.

PPP is associated with complex T-cell activation patterns, which may be why many biologics that target individual T helper cell populations have shown limited efficacy in clinical trials

About the trial

The DELTA NEXT trial plans to recruit up to 135 patients with active, chronic, mild to severe PPP for whom topical corticosteroids are inadequate or inadvisable. Participants will be recruited across 40-45 sites in the United States, Canada, the United Kingdom, Germany, and Poland.

Currently, delgocitinib cream is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under review in other markets, including the United States.