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

J Am Acad Dermatol. 2025 Jul;93(1):95-103. doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11.

Abstract

Background: Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE).

Objective: The objective of this trial was 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 treatment period in the DELTA 1 and 2 trials were treated on an as-needed basis with twice-daily delgocitinib cream for 36 weeks (n= 801). Patients with Investigator's Global Assessment for CHE (IGA-CHE) ≥2 received treatment until IGA-CHE ≤1 was achieved. The primary endpoint was the number of treatment-emergent adverse events. 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; patient years of observation = 535.7), with most frequent adverse events being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%) and HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to week 36 (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 week 36 (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 patients with CHE for up to 52 weeks.

Trial registration: ClinicalTrials.gov NCT04949841 and NCT04871711 NCT04872101 NCT04949841.

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Chronic Disease
  • Drug Administration Schedule
  • Eczema* / diagnosis
  • Eczema* / drug therapy
  • Female
  • Hand Dermatoses* / diagnosis
  • Hand Dermatoses* / drug therapy
  • Humans
  • Male
  • Middle Aged
  • Pyrimidines* / administration & dosage
  • Pyrimidines* / adverse effects
  • Pyrroles
  • Severity of Illness Index
  • Skin Cream
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • delgocitinib
  • Pyrimidines
  • Pyrroles

Associated data

  • ClinicalTrials.gov/NCT04949841 and NCT04871711
  • ClinicalTrials.gov/NCT04872101
  • ClinicalTrials.gov/NCT04949841