A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 58
- 主要终点
- Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
研究概览
简要总结
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
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)
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
- •Voluntarily signed informed consent to participate in the study;
- •Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;
- •EASI score ≥16 at screening and baseline;
- •IGA score ≥3 (moderate) at both screening and baseline;
- •BSA ≥10% at both screening and baseline;
- •Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
排除标准
- •Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;
- •Any of the following laboratory abnormalities at screening:
- •Serum creatinine: >1.5 mg/dL
- •AST or ALT: ≥2.5 times the upper limit of normal (ULN)
- •Neutrophil count: <1.5×10³/μL
- •Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;
- •Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
研究组 & 干预措施
Arm A
Subcutaneous administration of placebo
干预措施: Placebo (Drug)
Arm B
Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)
干预措施: KHK4083 (Drug)
Arm C
Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)
干预措施: KHK4083 (Drug)
Arm D
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)
干预措施: KHK4083 (Drug)
Arm E
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)
干预措施: KHK4083 (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
时间窗: Baseline to Week 16
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
次要结局
- Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16(Baseline to Week 16)
- Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score(Baseline to Week 16)
- Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score(Baseline to Week 16)
- Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score(Baseline to Week 16)
- Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16(Baseline to Week 16)
- Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)(Baseline to Week 16)
- Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score(Baseline to Week 16)
- Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score(Baseline to Week 16)
- Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score(Baseline to Week 16)
- Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score(Baseline to Week 16)
- Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)(Baseline to Week 16)
- EASI Score at Each Time Point(56 Weeks)
- Percent Change From Baseline in EASI Score at Each Time Point(56 Weeks)
- Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point(56 Weeks)
- SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point(56 Weeks)
- Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point(56 Weeks)
- Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point(56 Weeks)
- Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point(56 Weeks)
- Pruritus Numerical Rating Scale (NRS) Score at Each Time Point(56 Weeks)
- Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point(56 Weeks)
- Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point(56 Weeks)
- Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point(56 Weeks)
- Dermatology Life Quality Index (DLQI) at Each Time Point(56 Weeks)