*LP0133-1401 Delgocitinib cream in moderate to severe CHE (DELTA 1)
Research type
Research Study
Full title
A phase 3 clinical trial to confirm efficacy and evaluate safety of twice-daily delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adult subjects with moderate to severe chronic hand eczema (DELTA 1)
IRAS ID
288581
Contact name
Pink Andrew
Contact email
Sponsor organisation
Leo Pharma A/S
Eudract number
2020-002960-30
Clinicaltrials.gov Identifier
NCT4871711
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
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%.
Many factors can contribute to hand eczema and there are several different sub-types including irritant contact dermatitis, atopic hand eczema, and hyperkeratotic eczema.
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 a randomised, double-blind trial to compare the effect on CHE symptoms and evaluate the safety of Delgocitinib cream 20mg/g to cream vehicle in adult participants with moderate-to-severe CHE.
The trial consists of 3 periods: 1 to 4-week screening period, 16-week treatment period, and 2-week safety follow-up. Participants will be randomised 2:1 to treatment with delgocitinib cream 20 mg/g or cream vehicle.
Eligible subjects who complete the treatment period will be invited to participate in an open-label long-term extension trial conducted under a separate protocol.
Study assessments will include blood tests, physical exam, ECG, questionnaires, patch testing and optional exit interview. Tape stripping will be done at selected sites (not in the UK).
This study is sponsored by Leo Pharma. Approximately 450 patients will be recruited globally with approximately 32 in the UK.
Summary of Results
The results of this trial support the following conclusions in adult subjects with moderate to severe CHE:
• The primary objective, the efficacy of treatment with delgocitinib cream 20 mg/g compared with cream vehicle, was demonstrated.
• The secondary objective, the health-related quality of life and efficacy of treatment with delgocitinib cream 20 mg/g compared with cream vehicle, was demonstrated.
• Treatment with delgocitinib cream 20 mg/g for 16 weeks was well tolerated and no safety concerns were identified, based on the reported AEs, laboratory data, vital signs, and ECGs.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0189
Date of REC Opinion
30 Apr 2021
REC opinion
Further Information Favourable Opinion