Clinical trial NCT06631170: Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis
Official title: A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients with Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis (AD)
Keywords: Roflumilast cream
Atopic dermatitis
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 351
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

Detailed description: This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥ 6 years at screening.
2. Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening.
3. Have stable disease for the past 4 weeks prior to screening.
4. Have mild or moderate AD at baseline.
5. Have BSA affected by AD of 3%-20% at baseline.
6. Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
7. Being in good health as judged by the Investigator.
8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
2. Previous treatment with roflumilast cream.
3. Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
9. Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.

Primary outcomes:
measure: Percentage of subjects with vIGA-AD success
timeFrame: Baseline, week 4
Secondary outcomes:
measure: In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success
timeFrame: Baseline, week 4
measure: Percentage of subjects with vIGA-AD of "clear" or "almost clear"
timeFrame: Baseline, week 4
measure: In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS
timeFrame: Baseline, week 4
measure: Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
timeFrame: Baseline, week 4
measure: Safety: treatment emergence adverse events
timeFrame: Up to 4 weeks
measure: Trough concentration (Ctrough)
timeFrame: Week 2, week 4
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The Second affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Aerospace General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, CMU
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Medical University Affiliated Second Hospital
state: Chongqing
city: Chongqing
country: China
facility: People's Hospital Affiliated to Chongqing Three Gorges Medical College
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: The Second affiliated Hospital of Xiamen Medical College
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Dongguan
country: China
facility: The Sixth People's Hospital of Dongguan
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Union Shenzhen Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Haikou
country: China
facility: The Fifth People's Hospital of Hainan Province
state: Hainan
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: TCM Hospital of Shi Jia Zhuang City
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Luoyang
country: China
facility: The Second Hospital affiliated to Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Children's Hospital Zhengzhou Children's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
city: Nanjing
country: China
facility: Sir Run Run Hospital Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: J.Y Hospital of TCM
state: Jiangsu
city: Wuxi
country: China
facility: People's hospital of Wuxi
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Nanchang
country: China
facility: The Second affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Dermatology Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Women and Children's Medical Center
state: Liaoning
city: Panjin
country: China
facility: Panjin Liaohe Oilfield Gem Flower Hospital
state: Liaoning
city: Baotou
country: China
facility: The First affiliated Hospital of Baotou College
state: Neimenggu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Hiser Medical Center of Qingdao
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Hospital
state: Shanghai
city: Xi'an
country: China
facility: The Second affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jiaxing
country: China
facility: The Second Hospital of Jiaxing
state: Zhejiang
city: Ningbo
country: China
facility: The Second Hospital of Ningbo
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
References: