A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adult… (NCT06004050) | Clinical Trial Compass
CompletedPhase 3
A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema
China362 participantsStarted 2023-09-05
Plain-language summary
The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Age 18 years or above at screening for adult participants and age 12-17 years at screening and baseline for adolescent participants.
✓. Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
✓. HESD itch score (weekly average) of ≥4 points at baseline. The baseline weekly average will be calculated from daily assessments of itch severity during the 7 days immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 itch scores out of the 7 days is required to calculate the baseline average score.
✓. Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
✓. Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
✓. A woman of childbearing potential (WOCBP) must use an acceptable method of birth control throughout the trial up until the last application of investigational medicinal product (IMP).
Exclusion criteria
✕. Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
✕. Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
What they're measuring
1
Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
. Clinically significant infection (e.g. impetiginized hand eczema) on the hands.
✕. Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the investigational medicinal product (IMP), or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
✕. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.