| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10066695 |
| E.1.2 | Term | Chronic hand dermatitis |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10040785 |
| E.1.2 | Term | Skin and subcutaneous tissue disorders |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To establish the dose-response relationship of twice daily applications of delgocitinib cream 1, 3, 8, and 20 mg/g and delgocitinib cream vehicle for 16 weeks in the treatment of subjects with mild to severe chronic hand eczema. |
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| E.2.2 | Secondary objectives of the trial |
Other objectives in this protocol
To compare the safety of twice daily applications of delgocitinib cream 1, 3, 8, and 20 mg/g with delgocitinib cream vehicle for 16 weeks in the treatment of subjects with mild to severe chronic hand eczema.
To evaluate the health-related quality of life and efficacy of twice daily applications of delgocitinib cream 1, 3, 8, and 20 mg/g compared to delgocitinib cream vehicle for 16 weeks in the treatment of subjects with mild to severe chronic hand eczema.
To evaluate the effect of delgocitinib on Staphylococcus aureus colonisation of the skin, skin microbiome, skin barrier function, and skin inflammation. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Age 18 years or above.
•Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
•Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
•Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
•Diagnostic patch testing performed within 3 years prior to the screening visit.
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| E.4 | Principal exclusion criteria |
• Concurrent skin diseases on the hands, e.g. tinea manuum.
• Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
•Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
• Systemic treatment with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine), immunomodulating drugs (e.g., janus kinase inhibitors), retinoids (e.g., alitretinoin), or corticosteroids within 4 weeks prior to baseline (inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for asthma or rhinitis may be used).
•Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
•Receipt of live attenuated vaccines 4 weeks prior to baseline.
•Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
•Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
•Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
•Other cutaneously applied therapy on the hands (except for the use of subject’s own emollients) within 1 week 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 1 week prior to baseline.
•Treatment with any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, and dupilumab):
o 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.
o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
•Clinically significant infection within 4 weeks 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:
o A systemic infection.
o A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
•Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening. Subjects with high risk of latent tuberculosis (e.g. prior residence in or travel to countries with high prevalence of tuberculosis, close contact with a person with active tuberculosis, or a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed) must be tested.
•History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications as determined by medical history and/or subject’s verbal report.
•Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.
•Any disorder, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infections, endocrine, metabolic, haematological, immunological, psychiatric, or major physical impairment, which is not stable in the opinion of the investigator and could:
o Affect the safety of the subject throughout the trial.
o Influence the findings of the trial or their interpretations.
o Impede the subject’s ability to complete the entire duration of the trial.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary endpoint
• Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement (IGA TS) from baseline to Week 16.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
Secondary endpoints
• Change in Hand Eczema Severity Index (HECSI) from baseline to Week 16.
• Time to IGA TS.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 5 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 20 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| Last visit of the last subject. Protocol definition: A subject is considered to have completed the trial if he/she has completed all periods (i.e., screening, treatment, and follow-up period). |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
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