A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Investigator's Global Assessment (IGA) score of 0/1 at Week 16
研究概览
简要总结
This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).
The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy.
详细描述
This study includes a 35-day screening period; a 16-week randomized, placebo-controlled treatment period (Period 1); a 36-week long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU).
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to four treatment groups:
Group 1: LNK01001 12 mg BID (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 2: LNK01001 24 mg BID (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter) Group 3: Placebo (Day 1 to Week 16)， LNK01001 12 mg BID (Week 16 and thereafter) Group 4: Placebo (Day 1 to Week 16)， LNK01001 24 mg BID (Week 16 and thereafter)
Starting at Week 4, rescue therapy is allowed if medically necessary and the following parameters are met:
At Week 4 through Week 24: subjects with < 50% reduction in EASI response at any two consecutive scheduled visits, compared to the Baseline EASI score.
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
- •Participants must be at least ≥18 and ≤75 years of age.
- •The subject has a diagnosis of atopic dermatitis for at least 1 year.
- •Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥
- •Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit.
排除标准
- •Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study.
- •Requirement of prohibited medications during the study.
- •Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- •History of malignancy or current diagnosis of malignancy before screening visit.
- •In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.
研究组 & 干预措施
Placebo / LNK01001 12 mg
o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 16 to Week 52.
干预措施: Placebo (Drug)
Placebo / LNK01001 24mg
o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 24 mg twice daily from Week 16 to Week 52.
干预措施: Placebo (Drug)
LNK01001 12 mg
o Period 1: Participants receive LNK01001 12 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 16 to Week 52.
干预措施: LNK01001 (Drug)
LNK01001 24 mg
o Period 1: Participants receive LNK01001 24 mg twice daily for 16 weeks. Period 2: Participants will continue on LNK01001 24 mg twice daily from Week 16 to Week 52.
干预措施: LNK01001 (Drug)
Placebo / LNK01001 12 mg
o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 16 to Week 52.
干预措施: LNK01001 (Drug)
Placebo / LNK01001 24mg
o Period 1: Participants receive a placebo twice daily for 16 weeks. Period 2: Participants will switch to receive LNK01001 24 mg twice daily from Week 16 to Week 52.
干预措施: LNK01001 (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
时间窗: Baseline and Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Eczema Area and Severity Index (EASI-75) at Week 16
时间窗: Baseline and Week 16
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
- Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16.(Baseline to week 52 other than Week 16.)
- Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16(Baseline and Week 16)
- Change from Baseline in Eczema Area and Severity Index at all visits.(Baseline to week 52)
- Eczema Area and Severity Index (EASI 75) at all visits other than Week 16(Baseline to week 52 other than Week 16)