A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
研究概览
简要总结
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above.
- •Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- •History of AD for ≥1 year.
- •AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
- •Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.
排除标准
- •AD lesion(s) on scalp at screening and/or baseline.
- •Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
- •Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
- •Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- •Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
- •Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
- •Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
- •Receipt of live attenuated vaccines within 4 weeks prior to baseline.
- •Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
- •History of any active skin infection within 1 week prior to baseline.
- •Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
研究组 & 干预措施
Delgocitinib cream 1 mg/g
Delgocitinib cream applied twice daily for 8 weeks
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 3 mg/g
Delgocitinib cream applied twice daily for 8 weeks
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 8 mg/g
Delgocitinib cream applied twice daily for 8 weeks
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream 20 mg/g
Delgocitinib cream applied twice daily for 8 weeks
干预措施: Delgocitinib cream (Drug)
Delgocitinib cream vehicle
Delgocitinib cream vehicle applied twice daily for 8 weeks
干预措施: Delgocitinib cream vehicle (Drug)
结局指标
主要结局
Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
时间窗: Week 0 to Week 8
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
次要结局
- EASI75 at Week 8(Week 0 to Week 8)
- Time to vIGA-AD TS(Week 0 to Week 8)
- Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.(Week 0 to Week 8)