A Phase Ib, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Clinical Effect, Safety and Tolerability of a Single Intravenous Infusion of GSK1070806 in Moderate to Severe Atopic Dermatitis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1
研究概览
简要总结
This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
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)
盲法说明
This is a double-blind study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Other than AtD, the presence of a significant skin morbidity that will influence the Investigator's ability to assess the severity of the disease (e.g. psoriasis, confirmed or suspected cutaneous T-cell lymphoma, autoimmune bullous disease, fixed drug reaction and Stevens Johnson Syndrome).
- •Participants with any uncontrolled medical conditions, other than AtD, that in the opinion of the investigator puts the participant at unacceptable risk or will likely interfere with study assessments or data integrity. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study.
- •Treatment with biologic agents (investigational and marketed monoclonal antibodies) within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosing on Day
- •Treatment with Janus Activated Kinase inhibitors (e.g. baricitinib, upadacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to dosing on Day
- •Mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors within 4 weeks of Screening.
研究组 & 干预措施
Group 1: GSK1070806
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
干预措施: GSK1070806 (Drug)
Group 1: Placebo
Participants received Placebo as intravenous infusion on Day 1.
干预措施: Placebo (Drug)
Group 2: Dupilumab-IR with GSK1070806
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
干预措施: GSK1070806 (Drug)
Group 2: Dupilumab IR with Placebo
Participants received Placebo as intravenous infusion on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1
时间窗: Baseline (Day 1) and at Week 12
EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The percent change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
次要结局
- Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1(At Week 12)
- Percent Change From Baseline in EASI Score at Week 12 in Group 2(Baseline (Day 1) and at Week 12)
- Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2(Up to Week 25)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2(Up to Week 24)
- Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2(Up to Week 24)
- Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2(Up to Week 24)
- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2(Up to Week 24)
- Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2(Up to Week 24)
- Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2(Up to Week 24)
- Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1(At Week 12)
- Change From Baseline in EASI Score at Week 12 in Group 1(Baseline (Day 1) and at Week 12)
- Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1(At Week 12)
- Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1(At Week 12)