NCT04804605已完成3 期
A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,220
- 试验地点
- 92
- 主要终点
- Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
详细描述
This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
- •Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
- •Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
- •Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
- •Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
- •Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
排除标准
- •Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
- •Subjects that use any Excluded Medications and Treatments.
- •Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- •Subjects with known genetic dermatological conditions that overlap with AD.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- •Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.
研究组 & 干预措施
ARQ-151 Cream 0.05%
Experimental
Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.
干预措施: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% (Drug)
结局指标
主要结局
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
时间窗: Up to 52 weeks
The number of participants with ≥1 TEAE(s) is reported.
次要结局
- Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment(Weeks 4, 12, 24, 36, and 52)
- Percentage of Participants With vIGA-AD Success(Weeks 4, 12, 24, 36, and 52)
- Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study(Weeks 4, 12, 24, 36, and 52)
- Percent Change From Baseline in EASI Score(Weeks 4, 12, 24, 36, and 52)
研究者
研究点 (92)
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