A phase 3 clinical trial to evaluate efficacy and safety of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle for a 16-week treatment period in adolescents 12-17 years of age with moderate to severe chronic hand eczema - DELTA-TEE

EO Pharma A/S0 个研究点目标入组 92 人开始时间: 2022年3月10日最近更新: 2022年8月8日

试验速览

暂无简介。

•- Age 12 to 17 years at screening and baseline.
•- 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).
•- Subjects who have a documented history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit - see protocol for definition of inadequate response) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks - see protocol for definition or important side effects or safety risks).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 92
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Concurrent skin disease on the hands, e.g tinea manuum.
•- 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 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.
•- Any disorder which is not stable and could affect the safety of the subject throughout the trial or impede the subject’s ability to complete the trial.

发起方

EO Pharma A/S