A 12-week Efficacy Evaluation of WBI-1001 Cream in Patients With Atopic Dermatitis: A Multi-centered, Double-blinded Study (6-week Placebo-controlled Phase Followed by a 6-week Non-placebo Controlled Phase).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 5
- 主要终点
- Investigator's Global Assessment (IGA) score
研究概览
简要总结
Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mild to moderate atopic dermatitis.
详细描述
A multi-centered, double-blinded Phase IIb study to evaluate the safety and efficacy of the non-steroid, anti-inflammatory WBI-1001 cream in the topical treatment of patients with mild to moderate atopic dermatitis, expressed as lesions up to 20% BSA. For the first 6 weeks patients will be randomized to one of three treatment groups simultaneously in a ratio of 1:1:1.
Group 1: vehicle cream (placebo), BID; Group 2: 0.5% WBI-1001 cream, BID; Group 3:1.0% WBI-1001 cream, BID. Patients randomized to treat all lesion areas.
After the first 6 weeks all patients will be treated, non-placebo controlled, with WBI-1001 cream. The Group 1 patients will enter a double-blinded phase for a further 6 weeks with half of them being treated BID with 0.5% and half with 1.0% WBI-1001 cream. Groups 2 and 3 will continue with their treatments unchanged for the remaining 6 weeks.
During the treatment period, patients will apply the cream (BID) from the kit that they have been provided, and they will visit the study centre at prescribed times for assessment of efficacy, safety and tolerability. After completion of the 12-week treatment period patients will have a 2-week follow-up visit.
Patients who withdraw from the study before Day 42 for reasons other than a treatment related AE will be replaced so that at least 40 patients per group will complete the placebo-controlled phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- 是
入选标准
- •Clinical diagnosis of chronic atopic dermatitis (Hanifin's criteria) for greater than 6 months with a minimum of 5% and a maximum of 20% BSA.
- •IGA scores of 2-4 at Day
- •WOCBP must have a negative serum beta-hCG pregnancy test before randomization, and they and their male partners must take pregnancy precautions for the duration of the study, as also must male patients.
- •Willing to comply with Protocol and attend all visits.
- •Provide written informed consent prior to entering study procedures.
- •Patient has no latent or active tuberculosis infection according to medical history or current examination and tests.
排除标准
- •Pregnancy or lactation.
- •Spontaneously improving or rapidly deteriorating atopic dermatitis.
- •Presence of atopic dermatitis on only hands and/or feet.
- •Any skin disease other than atopic dermatitis that might interfere with clinical assessment or put patient at risk.
- •Active allergic contact dermatitis or other non-atopic forms of atopic dermatitis.
- •Other concommitant serious illness or medical condition, virus or renal insufficiency, or clinically significant abnormality that could put patient at risk during the study.
- •History of neurological/psychiatric disorders including psychotic disorders, dementia or any other reason that would interfere with the patient's participation.
- •Systemic immunomodulatory therapies for other conditions within 4 weeks prior to the baseline visit.
- •Any phototherapy, photochemotherapy or systemic atopic dermatitis therapy within 2 weeks of the baseline visit.
- •Prolonged exposure to natural or artificial sources of UV within 4 weeks prior to baseline visit or intention to have such exposure during the study.
- •Topical atopic dermatitis therapies (including corticosteroids and calcineurins) in the areas to be treated within 2 weeks prior to baseline.
- •Alcohol abuse in the last 2 years.
- •Allergic history to any of the non-medical ingredients of the study cream.
- •Treatment with an investigational drug within one month of Day 0 or current participation in another clinical trial.
研究组 & 干预措施
Group 1
0%; vehicle cream
干预措施: WBI-1001 (Drug)
Group 2
0.5% WBI-1001 cream
干预措施: WBI-1001 (Drug)
Group 3
1.0% WBI-1001 cream
干预措施: WBI-1001 (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) score
时间窗: The change from baseline to 6 weeks.
To evaluate the efficacy of the 0.5% and 1.0% WBI-1001 creams in comparison with the vehicle placebo.
次要结局
- Eczema Area and Severity Index (EASI) score(The change from baseline to 6 weeks.)
- Scoring Atopic Dermatitis (SCORAD) Index.(Change from baseline to 6 weeks.)
- Clinical laboratory tests (haematology, urine) and vital signs.(From baseline through 12 weeks+2 weeks follow-up)
- Adverse events(From baseline through 12 weeks+2 weeks follow-up)
- BSA and pruritus.(From baseline through 6 weeks.)
- Longterm change in IGA score of WBI-1001 cream groups.(Change from baseline through 12 weeks)
- Statistically significant improvement in the rate of "Treatment Success" with 0.5% and 1.0% WBI-1001 creams compared with placebo.(First 6 weeks)