Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials

Melinda Gooderham, Department of Medicine, Queens University, Kingston, Ontario, Canada; SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada. Electronic address: mgooderham@centrefordermatology.com.
Sonja Molin, Division of Dermatology, Queen's University, Kingston, Ontario, Canada.
Robert Bissonnette, Innovaderm Research, Montreal, Quebec, Canada.
Margitta Worm, Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin, Berlin, Germany.
Marie-Noëlle Crépy, Department of Dermatology, University Hospital of Centre of Paris, Cochin Hospital, AP-HP, Paris, France; Department of Occupational and Environmental Diseases, University Hospital of Centre of Paris, Hôtel-Dieu Hospital, AP-HP, Paris, France.
Luca Stingeni, Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
Richard B. Warren, Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Sibylle Schliemann, Department of Dermatology, University Hospital Jena, Jena, Germany.
Marie-Louise Schuttelaar, University Medical Centre Groningen, University of Groningen, The Netherlands.
Silvia Ferrucci, Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Esther Serra-Baldrich, Department of Dermatology, Sant Pau Hospital, Barcelona, Spain.
Jonathan I. Silverberg, Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Cherry Lou Balita-Crisostomo, LEO Pharma A/S, Ballerup, Denmark.
Marie Louise Oesterdal, LEO Pharma A/S, Ballerup, Denmark.
Ursula Plohberger, LEO Pharma A/S, Ballerup, Denmark.
Tove Agner, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Document Type

Journal Article

Publication Date

3-11-2025

Journal

Journal of the American Academy of Dermatology

DOI

10.1016/j.jaad.2025.03.008

Keywords

CHE; Chronic Hand Eczema; DELTA 3; clinical trial; contact dermatitis; delgocitinib cream; hand eczema; inflammation; long-term; moderate to severe; open-label; phase 3; safety

Abstract

BACKGROUND: There are no topical treatments that have been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE). OBJECTIVE: To evaluate the long-term safety and efficacy of delgocitinib cream 20 mg/g as needed for 36 weeks in adults with CHE. METHODS: In phase 3 open-label DELTA 3 (NCT04949841), patients who completed the 16-week(W) treatment period in DELTA 1 and 2 were treated on an as-needed basis with twice-daily delgocitinib for 36 weeks (n=801). Patients with Investigator's Global Assessment for CHE (IGA-CHE)≥2 received treatment until IGA-CHE≤1 was achieved. Primary endpoint was number of treatment-emergent adverse events (AEs). Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores. RESULTS: Delgocitinib was well tolerated (n=801; R=231.1; PYO=535.7), with most frequent AEs being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%), HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to W36 (30.0% and 58.6%/36.6%, respectively) among delgocitinib-treated patients in the parent trials. Among those previously treated with cream vehicle, corresponding response rates improved from DELTA 3 baseline (9.1% and 23.7%/12.0%, respectively) to W36 (29.5% and 51.5%/35.7%). LIMITATIONS: Open-label trial. CONCLUSION: Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in CHE patients up to 52 weeks.

Department

Dermatology

Link to Full Text

Share

COinS