A phase 3 clinical trial to evaluate efficacy and safety of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adolescents 12-17 years of age with moderate to severe chronic hand eczema
LEO Pharma A/S
Chronic hand eczema (CHE) is an inflammatory disorder occurring on the hands or wrists and persists for more than 3 months or returns twice or more in 12 months. Few studies have dealt with hand eczema in paediatric populations and limited information on the prevalence of hand eczema in paediatrics is available.
CHE is generally difficult to treat and presents with periods of flares and remissions. There are currently no approved treatment options indicated for adolescents with moderate to severe CHE. The currently available treatment options are limited to those approved for other skin diseases and either lack documented treatment effect or are limited by restrictions of long-term use due to safety concerns. Thus, there is a high unmet medical need for new therapies for these patients.
Delgocitinib acts by blocking the signalling pathways that activate immune and inflammatory cells which are responsible for triggering CHE symptoms. The efficacy and safety of delgocitinib cream has been demonstrated in a clinical trial in adults with mild to severe CHE. For all doses, delgocitinib was well tolerated.
The purpose of this trial is to evaluate efficacy and safety of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle (placebo) in adolescents 12 to 17 years of age with moderate to severe CHE.
Sites with the experience of treating adolescent patients with CHE will participate in the trial.
The trial consists of 3 periods: 4-week screening period, 16-week treatment period, and 2-week safety follow-up. Study assessments will include physical examinations, blood tests, urinalyses, ECGs, and questionnaires.
This study is sponsored by LEO Pharma. Approximately 92 participants will be recruited globally with approximately 8 in the UK.
South Central - Hampshire A Research Ethics Committee
Date of REC Opinion
10 Jun 2022
Further Information Favourable Opinion