A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
研究概览
简要总结
Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.
详细描述
The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups.
Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)
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)
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
- •participants between ≥ 18 and ≤75 years of age.
- •subjects meet Hanifin and Rajka criteria.
- •subjects meet moderate to severe AD criteria.
- •inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.
排除标准
- •current use of topical treatment for AD within 2 weeks before baseline visit.
- •prior exposure to Janus Kinase (JAK) inhibitor.
- •prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.
- •Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.
- •Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC<3×10e9/L, neutrophil<1.2×10e9/L, platelet<100×10e9/L, hemoglobin<85 g/L; Aspartate aminotransferase or alanine aminotransferase>1.5×ULN, or total bilirubin>1.5×ULN; Serum creatinine>1.2×ULN.
研究组 & 干预措施
LNK01001 Dose A
Participants will receive LNK01001capsule Dose A BID orally for 12 weeks.
干预措施: LNK01001 Dose A (Drug)
LNK01001 Dose B
Participants will receive LNK01001capsule Dose B BID orally for 12 weeks.
干预措施: LNK01001 Dose B (Drug)
placebo
Participants will receive a Placebo capsule BID orally for 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
时间窗: week 12
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
次要结局
- Change From Baseline in Worst Pruritus Numerical Rating Scale(NRS) Score(Week 4,8,12)
- Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)(Week 4,8,12)
- Percent Change from Baseline in EASI Score(Week 4,8)
- Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in Investigator Global Assessment (IGA)(Week 4,8,12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Week 4,8,12)
- Percentage of Participants Achieving an Investigator Global Assessment (IGA) response(Week 4,8,12)
- Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)(Week 4,8,12)
- Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)(Week 4,8,12)
- Percent Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Score(Week 4,8,12)
- Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)(Week 4,8,12)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Score(Week 4,8,12)