A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 39
- 主要终点
- Number of Participants With ≥1 Adverse Event (AE)
研究概览
简要总结
This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants legally competent to sign and give informed consent or (for adolescents) assent.
- •Males and females ages 9 years and older (inclusive) at the time of consent.
- •Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
- •Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- •Cohort 1 only:
- •Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.
- •Cohort 2 subjects that have not participated in a prior ARQ-154 study:
- •Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- •Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
- •An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day
- •Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day
- •Cohort 2 subjects that have participated in a prior ARQ-154 study:
- •Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
- •Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
排除标准
- •Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- •Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- •Subjects unable to apply investigational product to the scalp due to physical limitation.
- •Known allergies to excipients in ARQ-154 foam.
- •Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
- •Known or suspected:
- •severe renal insufficiency or moderate to severe hepatic disorders
- •history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- •Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
- •Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- •Subjects who are unable to communicate, read or understand the local language, 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 that live in the same household of enrolled subjects.
- •Cohort 1 only:
- •Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
- •Subjects that use any Excluded Medication and Treatments.
- •Cohort 2 only:
- •Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
- •Subjects with PHQ-8 >10 or modified PHQ-A >10 at Screening or Day
- •Cohort 2 subjects that have participated in a prior ARQ-154 study:
- •Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
研究组 & 干预措施
Long-term safety of ARQ-154
Open-label, Long-term Safety of ARQ-154
干预措施: ARQ-154 (Drug)
结局指标
主要结局
Number of Participants With ≥1 Adverse Event (AE)
时间窗: Up to 52 weeks
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Number of Participants With ≥1 Serious Adverse Event (SAE)
时间窗: Up to 52 weeks
The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
次要结局
- IGA Treatment-Free Interval(Weeks 4, 12, 24, 36, and 52)
- Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear(Weeks 4, 12, 24, 36, and 52)
- Duration of IGA Success(Weeks 4, 12, 24, 36, and 52)
- Achievement of IGA Success(Weeks 4, 12, 24, 36, and 52)