A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 23
- 主要终点
- Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
研究概览
简要总结
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
详细描述
This is a placebo controlled study where subjects with severe chronic hand eczema will be randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will continue on the same assigned treatment dose during the second part of the study (Week 16 to Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to any study-related procedure being performed
- •Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.
- •Subject has a history of severe CHE for at least 6 months prior to baseline
- •Subject has hand eczema refractory to high potency or ultra-high potency topical corticosteroids
- •Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or
- •Subject has been using an emollient on their hands and feet (except those containing urea or salicylic acid) every day at the same frequency for at least 1 week prior to Day 1
- •Subject has a body mass index (BMI) ≤ 38 kg/m
- •Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day
- •Willing and able to comply with clinical visits and study related procedures.
排除标准
- •Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
- •A serious uncontrolled condition including hypertension, active tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer.
- •Active skin infections of the hands and/or feet
- •Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
- •Pregnant or breast-feeding women
- •Known hypersensitivity to ASN002 or its excipients
- •Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
- •Subject has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
研究组 & 干预措施
ASN002 40 mg
40 mg ASN002
干预措施: ASN002 (Drug)
ASN002 80 mg
80 mg ASN002
干预措施: ASN002 (Drug)
Placebo oral tablet
Matching placebo for ASN002 doses
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percent Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)
时间窗: 16 weeks
Percent change from baseline in hand mTLSS at Week 16. The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, edema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale. The ratings are added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease)
次要结局
- Change From Baseline in Hand Physician Global Assessment (PGA)(16 weeks)
- Change From Baseline in Hand Patient Global Assessment (PaGA)(16 weeks)