A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Success rate in Investigator's Global Assessment at Week 4
研究概览
简要总结
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
详细描述
- Screening period is defined as the interval between the day of obtaining informed consent and the day of the baseline visit (0-30 days). The investigator performs a screening examination after obtaining informed consent from the subject's legal guardian (and, if possible, after obtaining consent from the subject).
- Assessment period (4 weeks double blind treatment period) is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at the baseline visit will be assigned to receive 0.3% or 1% OPA-15406 ointment or comparator (vehicle [Placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of the Week 4 visit, a withdrawal visit will be performed for that subject.
- Trial period(4 weeks double blind Treatment) The trial period for an individual subject is the period from the day of obtaining the written informed consent from the subject's legal guardian to the day of the Week 4 visit or withdrawal visit. For subjects who miss the Week 4 visit or withdrawal visit, the termination date, will be the date, as determined by the investigator, when the subject is withdrawn from the trial. The trial period does not include a follow-up period for AE.
- 24 weeks, Open label, long term treatment period To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 0.3% or 1% OPA-15406 open treatment for up to 24 weeks based on the inform consent of the subjects.
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: Either male or female. Age: 2 to 14 years, inclusive (at time of obtaining informed consent) (only for 4 weeks double blind treatment).
- •Diagnosis of AD based on the criteria of Hanifin and Rajka (see Appendix 1).
- •Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit(only for 4 weeks double blind treatment).
排除标准
- •Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
研究组 & 干预措施
0.3% OPA-15406 Ointment
The 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.
干预措施: 0.3% OPA-15406 Ointment (Drug)
1% OPA-15406 Ointment
The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.
干预措施: 1% OPA-15406 Ointment (Drug)
0% OPA-15406 Vehicle
The 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated.
干预措施: 0% OPA-15406 vehicle (Other)
结局指标
主要结局
Success rate in Investigator's Global Assessment at Week 4
时间窗: 4 weeks
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades from baseline. Subjects with missing Investigator's Global Assessmen data will be handled as non-responders.
次要结局
- Change from baseline in Investigator's Global Assessment at Week 4(4 weeks)
- Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.(4 weeks)
- Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4.(4 weeks)
- Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4(4 weeks)
- Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4(4 weeks)
- Change from baseline in Verbal Rating Scale for Pruritus at Week 4(4 weeks)
- Change from baseline in Verbal Rating Scale for pruritus up to Day 7(7 Days)
- Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4(4 Weeks)
- Change from baseline in the total affected Body Surface Area (percent) at Week 4(4 weeks)
- Success rate in Investigator's Global Assessment(24 Weeks)
- Time to Investigator's Global Assessment response(Within 24 Weeks)
- Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index)(24 Weeks)
- Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index)(24 Weeks)
- Change from baseline in the total score of Patient-Oriented Eczema Measure(24 Weeks)
- Success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index)(24 Weeks)
- Change from baseline in Investigator's Global Assessment(24 Weeks)
- Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score(24 Weeks)
- Change from baseline in the total affected Body Surface Area (percent)(24 Weeks)