A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Week 16 in EASI Score
研究概览
简要总结
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
详细描述
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.
Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years inclusive at the time of consent.
- •Body mass index between 19.0 and 40.0 kg/m2 inclusive.
- •Documented history of chronic AD, for at least 1 year prior to screening Visit
- •Meets at minimum 1 of the criteria, as follows:
- •History of inadequate response to topical medications for AD
- •Subject intolerance to treatment with topical medications for AD, or
- •Topical medications are otherwise medically inadvisable
- •AD that affects ≥ 10% of the body surface area (BSA).
- •An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
- •An IGA score of ≥ 3.
排除标准
- •Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- •Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
- •Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
- •Known active allergic or irritant contact dermatitis.
研究组 & 干预措施
MEDI3506 at dose level 1
Participant will receive multiple doses of MEDI3506 at dose level 1.
干预措施: MEDI3506 (Drug)
MEDI3506 at dose level 2
Participant will receive multiple doses of MEDI3506 at dose level 2.
干预措施: MEDI3506 (Drug)
MEDI3506 at dose level 3
Participant will receive multiple doses of MEDI3506 at dose level 3.
干预措施: MEDI3506 (Drug)
Placebo
Participant will receive multiple doses of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 16 in EASI Score
时间窗: Week 16
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
次要结局
- Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS(Week 16)
- SCORAD: Percent Change From Baseline to Week 16(Week 16)
- Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD(Week 16)
- Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS(Week 16)
- Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16(Week 16)
- Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16(Week 16)
- Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16(Week 16)
- Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16(Week 16)
- Heart Rate Taken During Vital Signs Assessment(Baseline, week 16 and week 24)
- Respiratory Rate Collected During Vital Signs Assessment(Baseline, week 16 and week 24)
- Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS(Week 16)
- Change From Baseline to Week 16 in DLQI(Week 16)
- Change From Baseline to Week 16 in POEM(Week 16)
- Serum MEDI3506 Concentration Profiles(Week 16 and week 24)
- Oral or Tympanic Temperature Taken During Vital Signs Assessment(Baseline, week 16 and week 24)
- Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance(Week 16 and week 24)
- Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16(Week 16)
- Change From Baseline to Week 16 in 5-D Itch(Week 16)
- Occurrence of Adverse Events(up to 24 weeks)
- Systolic Blood Pressure Taken During Vital Signs Assessment(Baseline, week 16 and week 24)
- Heart Rate (Beats/Min) Recorded on ECGs(Baseline, week 16 and week 24)
- QT (Miliseconds) Recorded on ECGs(Baseline, week 16 and week 24)
- Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods(up to 24 weeks)
- Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology(up to 24 weeks)
- Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry(up to 24 weeks)
- Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis(up to 24 weeks)
- Left Ventricular Ejection Fraction Measured by Echocardiogram(Baseline and week 16)