Actively Recruiting
Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-05-16
189
Participants Needed
31
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.
CONDITIONS
Official Title
Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate and sign informed consent
- Aged 6 years or older, any gender
- Clinical diagnosis of plaque psoriasis with disease duration of at least 6 months for those aged 12 or older, or at least 3 months for those aged 6 to 11, and stable for the last 4 weeks
- Psoriasis involving 2%-20% body surface area excluding scalp, palms, and soles
- Investigator Global Assessment (IGA) score of 2 or higher
- Psoriasis Area and Severity Index (PASI) score of 2 or higher excluding scalp, palms, and soles
- Females of childbearing potential must have negative pregnancy tests and agree to use reliable contraception from 4 weeks before first dose until 2 months after last dose
- Male subjects must agree to use highly effective contraception from first dose until 4 months after last dose
- Free of other medical conditions that would interfere with safety or efficacy assessments based on medical history and lab tests
You will not qualify if you...
- Non-plaque forms of psoriasis or drug-induced psoriasis
- Skin disorders or infections that could interfere with study assessments
- Use of etanercept within 4 weeks, adalimumab/infliximab within 8 weeks, or other biologics within 12 weeks before first dose
- Use of systemic psoriasis treatments or immunosuppressants within 4 weeks before first dose
- Use of topical psoriasis treatments or agents affecting psoriasis assessment within 2 weeks before first dose
- Use of psoralen plus ultraviolet A or ultraviolet B phototherapy within 4 weeks before first dose
- Prior use of ZORYVE cream/foam or oral roflumilast or other PDE4 inhibitors within 4 weeks before first dose
- Use of antihistamines or potent CYP450 enzyme inhibitors or inducers within 2 weeks before first dose or inability to discontinue during study
- Use of lithium-containing agents or antimalarials within 4 weeks before first dose
- Expected excessive exposure to natural/artificial light or LED irradiation at treatment area during study
- Planned medication changes affecting psoriasis efficacy evaluation
- Known hypersensitivity to roflumilast or product excipients
- HIV, hepatitis B or C infection, or active syphilis based on screening
- Moderate to severe hepatic impairment or abnormal liver/kidney function at screening
- History or risk of major depressive disorder or suicidality
- Female subjects who are lactating or planning fertility during study
- Alcohol or drug abuse within 6 months before screening
- Major surgery within 4 weeks before first dose or planned during study
- Recent cancer diagnosis within 5 years except certain treated cancers
- Prior active infection requiring antibiotics or antifungals within 7 days before first dose
- Any serious medical or mental condition affecting participation or safety
- Family members of study staff or already enrolled participants
- Participation in other interventional clinical trials within 3 months prior to first dose
- Other investigator-determined reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
2
People's Hospital of Peking University
Beijing, China, 100032
Actively Recruiting
3
Beijing Children's Hospital, Capital Medical University
Beijing, China
Actively Recruiting
4
Beijing Tongren Hospital, Capital Medical University
Beijing, China
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5
Children's Hospital of Hunan Province
Changsha, China
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6
The Second Xiangya Hospital of Central South University
Changsha, China
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7
Affiliated Hospital of Chengde Medical College
Chengde, China
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8
Sichuan Provincial People's Hospital
Chengdu, China
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9
The Second People's Hospital of Chengdu
Chengdu, China
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10
Affiliated Hospital of Chongqing Three Gorges Medical College
Chongqing, China
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11
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
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12
The Sixth People's Hospital of Dongguan
Dongguan, China
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13
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, China
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14
Dermatology Hospital of Southern Medical University
Guangzhou, China
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15
Hainan Fifth People's Hospital
Haikou, China
Actively Recruiting
16
The First People's Hospital of Hangzhou
Hangzhou, China
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17
Zhejiang Provincial People's Hospital
Hangzhou, China
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18
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
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19
Ji'nan Central Hospital
Ji'nan, China
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20
The First Hospital of Jilin University
Jilin, China
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21
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Jinhua, China
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22
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
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23
Affiliated Hospital of Nantong University
Nantong, China
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24
Sanmenxia Central Hospital
Sanmenxia, China
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25
Shanghai Skin Disease Hospital
Shanghai, China
Actively Recruiting
26
The Second Affiliated Hospital of South Anhui Medical College
Wuhu, China
Actively Recruiting
27
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
28
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
29
The First People's Hospital of Yancheng
Yancheng, China
Actively Recruiting
30
Zhengzhou Central Hospital
Zhengzhou, China
Actively Recruiting
31
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Actively Recruiting
Research Team
H
Huadong Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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