LEO Pharma Starts Phase 2a DELTA NEXT Trial of Delgocitinib Cream for Palmoplantar Pustulosis

BALLERUP, Denmark – LEO Pharma A/S, a key player in medical dermatology, has commenced the DELTA NEXT trial, a phase 2a proof-of-concept study. This trial is designed to investigate the potential efficacy and safety of delgocitinib cream, in comparison to a placebo vehicle, for the treatment of adults suffering from mild to severe Palmoplantar Pustulosis (PPP). Following the completion of Phase 3 DELTA trials focused on Chronic Hand Eczema (CHE), PPP marks the first condition to be studied with delgocitinib cream.

Christophe Bourdon, the CEO of LEO Pharma, highlighted the significance of this trial as a vital step forward in the development of delgocitinib cream. He emphasized the limited treatment options currently available for PPP, which can drastically impair the quality of life, and expressed hope that this new therapy could offer essential relief for patients affected by this challenging condition.

PPP is a chronic skin ailment distinguished by recurring episodes of non-infectious pustules, along with redness, blistering, and scaling on the hands and feet. It carries a high patient burden, often leading to significant pain, fatigue, and can be exacerbated by triggers like smoking, infections, and stress. Additionally, it is linked with other health issues such as thyroid dysfunction and metabolic syndrome. Currently, there are no approved advanced systemic treatments for PPP in the U.S. or Europe, and the complex T-cell activation patterns associated with PPP pose challenges for treatments targeting specific T helper cell populations.

The active ingredient in delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor, which blocks the activity of all four JAK enzymes involved in inflammatory processes. The DELTA NEXT trial aims to assess whether inhibiting multiple JAKs can effectively treat PPP. Dr. Robert Bissonnette, the international coordinating investigator on the trial and Chairman at Innovaderm in Montreal, Canada, has observed the severe impact of PPP on patients' lives, noting the urgent need for effective therapies as current options remain scant.

The trial will recruit up to 135 participants with active, chronic, mild to severe PPP for whom traditional topical corticosteroids are insufficient or unsuitable. These participants will be enrolled across 40-45 locations spanning the United States, Canada, the United Kingdom, Germany, and Poland. They will be randomly assigned in a 2:1 ratio to receive either the delgocitinib cream or the cream vehicle.

Delgocitinib cream is already approved in the European Union, the United Kingdom, Switzerland, and the United Arab Emirates for adults with moderate to severe CHE when traditional topical corticosteroids are ineffective or inappropriate. It is currently under review in additional markets, including the United States.

For LEO Pharma, this trial represents a continuation of their commitment to dermatological innovation. With a heritage in developing cutting-edge skin health solutions, LEO Pharma serves nearly 100 million patients annually in over 70 countries. Through such trials and innovations, the company seeks to make a significant impact on the lives of individuals suffering from skin conditions worldwide. The DELTA NEXT trial is a promising endeavor in LEO Pharma’s extensive portfolio aimed at addressing unmet medical needs in dermatology.