NCT03754309已完成2 期
A Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 19
- 主要终点
- Percentage change in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.
详细描述
Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adults (greater than or equal to [>=] 18 years but less than [<] 75 years of age) with Atopic Dermatitis (AD) for 1 year or longer at Baseline (Day 1; prior to first administration of Investigational Medicinal Product [IMP]).
- •Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- •validated Investigator Global Assessment (vIGA) of 3 or 4 at Baseline.
- •AD involvement of 10 percent or more of body surface area at Baseline.
- •Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.
- •Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for at least 7 consecutive days before Baseline.
- •Able and willing to comply with requested study visits/telephone visits and procedures.
- •Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
- •Able and willing to provide written informed consent.
排除标准
- •Recent treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
- •Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
- •Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
- •Laboratory values at the Screening Visit:
- •a. Serum creatinine > 1.6 milligrams per deciliter (mg/dL) (141 micromole per liter [mcmol/L]) in female participants and > 1.9 mg/dL (168 mcmol/L) in male participants;
- •b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
- •c. Platelet count < 100*10^9/L;
- •d. Haemoglobin (Hb): Male < 13.5 g/dL and Female <12 g/dL;
- •e. White blood cell count (WBCC) < 3.0*10^9/L;
- •f. Absolute neutrophil count < 2.0*10^9/L;
- •g. Absolute lymphocyte count < 0.5*10^9/L;
- •h. Total bilirubin > ULN.
- •Participation in any other clinical study, including non-interventional studies.
研究组 & 干预措施
KY1005 lower dose
Experimental
Low dose KY1005
干预措施: KY1005 (Drug)
KY1005 higher dose
Experimental
High dose KY1005
干预措施: KY1005 (Drug)
Placebo
Placebo Comparator
Matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in Eczema Area and Severity Index (EASI)
时间窗: Baseline to day 113
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Baseline to day 113
次要结局
- Percentage and absolute change from Baseline in EASI over time(Baseline to day 113)
- Percentage of patients with at least a 50% reduction in EASI (EASI 50)(Baseline to day 113)
- Percentage of patients with at least a 90% reduction in EASI (EASI 90)(Baseline to day 113)
- Change in Dermatology Quality of Life Index (DLQI)(Baseline to Day 113)
- Percentage of patients with at least a 75% reduction in EASI (EASI 75)(Baseline to day 113)
- Change in Validated Investigator Global Assessment (vIGA)(Baseline to day 113)
- Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index(Baseline to day 113)
- Change in Numerical Rating Scale (NRS) for pruritus(Baseline to day 113)
- Change in epidermal thickness(Baseline to day 113)
- Change in keratin 16 staining of skin biopsies(Baseline to day 113)
- Percentage of patients with a response of vIGA 0 or 1(Baseline to day 113)
- Change in SCORing of Atopic Dermatis (SCORAD) Index(Baseline to day 113)
- Change in affected body surface area (BSA)(Baseline to day 113)
- Change in Patient Orientated Eczema Measure (POEM)(Baseline to Day 113)
研究者
研究点 (19)
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