* LP0133-1403 Delgocitinib Open label extension (DELTA3)

• Research type

  Research Study

• Full title

  A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

• IRAS ID

  297419

• Contact name

  Andrew Pink

• Contact email

  andrew.pink@kcl.ac.uk

• Sponsor organisation

  Leo Pharma A/S

• Eudract number

  2020-002962-15

• Clinicaltrials.gov Identifier

  NCT04949841

• Duration of Study in the UK

  1 years, 11 months, 14 days

• Research summary

  Chronic Hand Eczema (CHE) is an inflammatory disorder occurring on the hands and wrists and persists for more than 3 months or returns twice or more in 12 months. Reported prevalence varies, but lifetime prevalence of hand eczema has been reported as almost 15%.
  CHE is generally difficult to treat and presents with periods of flares and remissions. Currently available treatment options either lack documented treatment effect or long-term use is restricted due to safety concerns. There is a high unmet medical need for new topical treatment of moderate to severe CHE with high efficacy and a good safety profile especially for long-term use.
  Delgocitinib blocks cytokine-mediated signalling pathways and suppresses the activation of immune and inflammatory cells. The efficacy and safety of delgocitinib in CHE has been demonstrated in a phase 2b trial with
  delgocitinib cream.
  This is an open label extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of delogocitinib cream 20mg/g, twice daily, for up to 36 weeks in adults with Chronic hand eczema.
  The trial consists of 3 periods: 4 week screening period (during participation in parent trial and baseline visit will coincide with week 16 visit in parent trial ), 36 week treatment period and a 2 week safety follow up period.
  Study assessments will include blood and urine tests, physical examination, ECG, participant and investigator assessment (questionnaires).
  The study is sponsored by Leo Pharma. Approximately 750 will be recruited globally (from DELTA1 and DELTA 2 studies) with approximately 27 in the UK, from DELTA1 study only.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  22/SC/0302

• Date of REC Opinion

  25 Jun 2021

• REC opinion

  Favourable Opinion