A Phase II, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of LNK01004 Ointment in Adults With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
研究概览
简要总结
This study will evaluate the efficacy and safety of two concentrations (0.3 percent [%] and 1%) of twice daily LNK01004 ointment for the topical treatment in adult subjects with atopic dermatitis. This is a multicenter, randomized, double-blind, vehicle-controlled, 3-arm, parallel-group, dose-finding study in adult subjects with atopic dermatitis. Two concentrations of LNK01004 ointment (0.3% and 1%) and a vehicle control ointment will be equally randomized and evaluated following application to all atopic dermatitis lesions (except on the scalp) twice daily (morning and evening) for 8 weeks.
This study will consist of 3 periods: up to 4 weeks screening, 8 weeks double-blind treatment, and 2 weeks post-treatment follow-up.
Approximately 75 subjects (25 subjects for each group) with moderate to severe AD will be enrolled overall.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years at screening.
- •Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for at least 3 months at screening.
- •Stable course of AD (not spontaneously improving or rapidly deteriorating) as determined by the investigator in the 3 weeks before screening.
- •IGA score of 3 to 4 at screening and baseline.
- •BSA of AD involvement, excluding the Scalp, Palms, and Soles, of 5% to 35% at screening and baseline.
- •Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
排除标准
- •Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would pose a significant risk to the participant or interfere with the interpretation of study data.
- •Concurrent conditions and history of:
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- •Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- •Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesion.
- •Any other concomitant non-skin disorder with the treatment that may interfere with the evaluation of AD.
- •Use of any of the following treatments within the indicated period before Baseline:
- •6 weeks: Dupilumab
- •5 half-lives or 12 weeks, whichever is longer: biologic agents (except dupilumab).
- •4 weeks: Janus kinase (JAK) inhibitors.
- •5 half-lives or 4 weeks, whichever is longer: Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4)-inhibitors, Ultraviolet (UV) light therapy, or traditional Chinese medicine.
- •2 weeks: Sedating antihistamines.
- •1 week: Topical AD treatments (except topical emollient treatments), including but not limited to TCS, TCIs, or topical PDE-4 inhibitors.
- •Hepatitis B surface antigen (HBs Ag) positive (+); HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab); Human immunodeficiency virus (HIV) positive (+).
- •Participants with the following hematologic abnormalities at screening:
- •ALT or AST ≥ 2 × ULN
- •TBiL ≥ 2 × ULN
- •Creatinine ≥ 1.5 × ULN
- •History of alcoholism or drug addiction within 6 months before screening or current alcohol or drug use.
- •Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
- •Participants who are pregnant, nursing, or planning a pregnancy during the study period.
- •Participants with known allergies to components or excipients of the test drug.
研究组 & 干预措施
Vehicle
Participants applied vehicle ointment BID for 8 weeks in DB period.
干预措施: Vehicle (Drug)
LNK01004 ointment 0.3%
Participants applied LNK01004 ointment 0.3% BID for 8 weeks in DB period.
干预措施: LNK01004 ointment 0.3% (Drug)
LNK01004 ointment 1.0%
Participants applied LNK01004 ointment 1.0% BID for 8 weeks in DB period.
干预措施: LNK01004 ointment 1.0% (Drug)
结局指标
主要结局
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8
时间窗: Baseline to week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 regions of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement). 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 total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
次要结局
- Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 8(Baseline to week 8)
- Percentage of Participants Who Achieve a ≥ 75% Improvement From Baseline in EASI (EASI-75) at Week 8(Baseline to week 8)
- Percentage of Participants Who Achieve a ≥ 90% Improvement From Baseline in EASI (EASI-90) at Week 8(Baseline to week 8)
- Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Week 2(Baseline to week 2)
- Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points at Week 8(Baseline to week 8)
- Percentage of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score at Week 8(Baseline to week 8)
- Number of Participants with Any Treatment-emergent Adverse Event (TEAE)(Baseline to week 10)
- Plasma Concentration of LNK01004(week 4,week 8)