NCT05355818已完成3 期
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 TEEN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 98
- 试验地点
- 38
- 主要终点
- Number of Participants With IGA-CHE Treatment Success at Week 16
研究概览
简要总结
The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life.
The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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).
- •Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.
- •Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.
排除标准
- •Concurrent skin diseases 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. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (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.
- •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.
研究组 & 干预措施
Cream vehicle
Placebo Comparator
Cream vehicle twice daily
干预措施: Cream vehicle (Drug)
Delgocitinib cream
Experimental
Delgocitinib cream 20 mg/g twice daily
干预措施: Delgocitinib (Drug)
结局指标
主要结局
Number of Participants With IGA-CHE Treatment Success at Week 16
时间窗: Week 16
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
次要结局
- Change in CDLQI Score From Baseline to Week 16(Week 16)
- Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16(Week 16)
- Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16(Week 16)
- Number of Participants With IGA-CHE Treatment Success at Week 2(Week 2)
- Change in CDLQI Score From Baseline to Week 16(Week 16)
- Number of Participants With HECSI-90 at Week 16(Week 16)
- Number of Participants With IGA-CHE Treatment Success at Week 8(Week 8)
- Number of Treatment Emergent AEs From Baseline up to Week 18(Week 18)
- Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16(Week 16)
- Number of Participants With IGA-CHE Treatment Success at Week 4(Week 4)
- Number of Participants With IGA-CHE Treatment Success at Week 12(Week 12)
研究者
研究点 (38)
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