Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

• Age 18 years or above at screening.
• 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.
• Subjects who have a documented recent history of inadequate response to treatment with 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).
• Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
• A woman of childbearing potential must use at least an acceptable method of birth control throughout the trial up until the last application of IMP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

-Concurrent skin diseases on the hands, e.g. tinea manuum.
-Active AD requiring medical treatment in regions other than the hands and feet.
-Active psoriasis on any part of the body.
-Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
-Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
-Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
-Use of tanning beds, phototherapy (e.g. UVB, UVA1, PUVA), or bleach baths on the hands within 28 days prior to baseline.
-Previous or current treatment with JAK inhibitors (including delgocitinib/ LEO 124249), systemic or topical.
-Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.
-Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
-Other transdermal or cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.
-Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
-Treatment with any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, and dupilumab)
•Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
•Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
-Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as
•A systemic infection.
•A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
-History of any known primary immunodeficiency disorder including a positive HIV virus test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject's verbal report.
-Any disorder which is not stable and could:
•Affect the safety of the subject throughout the trial.
•Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.
-Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with moderate to severe CHE.;Secondary Objective: - To evaluate the safety of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects<br>with moderate to severe CHE.;Primary end point(s): Primary endpoint:<br>• IGA-CHE TS at Week 16.;Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary endpoints:<br>• HECSI 75 at Week 16.<br>• HECSI 75 at Week 8.<br>• HECSI 90 at Week 16.<br>• IGA CHE TS at Week 8.<br>• IGA CHE TS at Week 4.<br>• Percentage change in HECSI score from baseline to Week 16.<br><br>Secondary endpoints:<br>• Number of treatment-emergent AEs from baseline up to Week 16. (Week 18 for subjects not participating in the LTE trial) per subject.<br><br> A full list of endpoints is provided in the protocol.;Timepoint(s) of evaluation of this end point: As specified for each endpoint

Updated 9/26/2023

Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema.

Recruitment & Eligibility

Study & Design

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