Leo Pharma's New Scientific Data to Cure Chronic Hand Eczema (CHE)

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Announcement

The LEO Pharma A/S a a leading medical dermatology company, revealed two late-breaking delgocitinib cream data for chronic hand eczema (CHE), featuring the findings for the DELTA TEEN phase 3 trial and the well-examined safety data from the phase 3 trials and five phase 2b trials. The 15th additional abstract was also showcased under Leo’s expanding scientific program at the 34th European Academy of Dermatology and Venereology (EADV) congress in Paris. The 16-week DELTA TEEN phase 3 clinical trial (N+98) calculated the safety and efficacy of delgocitinib cream in adolescents aged ranging from 12-17 with extreme to moderate CHE, especially for whom topical corticosteroids are not suitable or inappropriate.

Study’s Outcome

The study achieved the primary endpoint as led by the investigator’s global assessment for CHE treatment success at the 16th week, which that marked by an IGA-CHE score of 0/1, indicating clear/almost clear with an improvement from the baseline. The delgocitinib cream was claimed to be significant in comparison to the cream vehicle, with around 63.5% of patients responding in the delgocitinib cream vs 29.2% in the cream vehicle market. The delgocitinib also achieved superiority against the cream vehicle across the major secondary outcome measures. No serious adverse events (AEs) were found, as all AEs reported with delgocitinib cream were moderate or mild in severity.

The total number of patients showing AEs was a little higher for delgocitinib cream in comparison to the cream vehicle. Most of the AEs assessed were possibly or probably linked to the trial drug, and AEs associated with the withdrawal from the permanent or trial discontinuation were reported accordingly, with low rates for delgocitinib cream. The delgocitinib did not receive any approval for patients aged 12-17 years, and the safety and efficacy in this group have not been examined by any health authority yet. Additionally, results from a massive analysis of five phase 2b and phase 3 trials were revealed as LEO’s second late-breaking introduction for CHE at EADV 2025.

Academic dermatologists at Charité Universitätsmedizin Berlin and adjunct associate professor of dermatology at Queen’s University, and coordinating investigator, Professor Sonja Molin, said, “The findings from the phase 3 DELTA TEEN trial are a hope for young people with CHE impact on their leisure and wellbeing activities. These results are empowering and have helped to take a step closer to the advancement of the standard of care.”