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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20230499 | Other Identifier | http://www.chinadrugtrials.org.cn/index.html |
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This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis.
Participants will:
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old (including threshold) with mild to moderate Atopic Dermatitis. Approximately 472 participants will be randomized 3:1 to PG-011 gel 3% BID, or placebo gel. In addition, approximately 10% of the overall study population will consist of adolescents. Participants with AD involvement of 3% to 20% BSA and IGA score of 2 to 3 will receive blinded study treatment for 8 weeks followed by an open-label treatment for 44 weeks, at last the safety follow-up for 2 weeks.
The study is to evaluate the efficacy and long-term safety of PG-011 gel 3% in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG-011Gel 3% | Experimental | Topically administered Pumecitinib Gel 3% to the skin twice daily for 52 or 44 weeks |
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| Vehicle Gel | Placebo Comparator | Topically administered the Vehicle Gel to the skin twice daily for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-011Gel | Drug | Twice daily for 52 weeks or 44 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8 | Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity. | 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0/1 at Week 8 | Proportion of participants achieving Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline at Week 8. | 8-week |
| Proportion change of eczema area and severity index (EASI) at each scheduled visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinghua Gao, Professor | Contact | +86-13940152467 | barrygao@hotmail.com | |
| Li Zhang, Professor | Contact | lizhang_100l@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao | First Hospital of China Medical University | Study Chair |
| ZhiQiang Xie, Professor | Beijing Hospital | Principal Investigator |
| Litao Zhang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
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| Label | URL |
|---|---|
| IGA, Investigator's Global Assessment | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| Vehicle | Drug | Vehicle Gel twice daily for 8 weeks |
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Proportion change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity. |
| Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Change of eczema area and severity index (EASI) score at each scheduled visit | Value change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit | The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The NRS score ranges from 0 to 10 points, higher score indicates greater intensity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit | Child Dermatology Life Quality Index (CDLQI) are designed to measure the impact of any skin disease on the lives of children. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit | Child Dermatology Life Quality Index (CDLQI) are designed to measure the impact of any skin disease on the lives of children. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Change from baseline of the Patient-oriented eczama Measure (POEM) score at each scheduled visit. | The Patient-oriented eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion change from baseline of affected body surface area (BSA) at each scheduled visit | Total body surface area(BSA) is 100%, and the proportion of affected body surface area(BSA) is ranged from 0 to100%, higher value indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion change from baseline of the Patient-oriented Eczama Measure (POEM) score at each scheduled visit. | The Patient-oriented Eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit. | Scoring Atopic Dermatitis(SCORAD) is a tool to assess the extent and severity of eczema and will be completed before, during, and after treatment has begun to determine whether the treatment has been effective. The SCORAD score ranges from 0 to 103, and higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit. | Scoring Atopic Dermatitis(SCORAD) is a tool to assess the extent and severity of eczema and will be completed before, during, and after treatment has begun to determine whether the treatment has been effective. The SCORAD score ranges from 0 to 103, and higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit. | Dermatology Life Quality Index (DLQI) is designed to measure the impact of any skin disease on the lives of adults.The DLQI score ranges from 0 to 30 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit. | Dermatology Life Quality Index (DLQI) is designed to measure the impact of any skin disease on the lives of adults.The DLQI score ranges from 0 to 30 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| The average time of the sites achieving Investigators Global Assessment(IGA) 0/1 from baseline | Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| The average time of the sites achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline | Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion of achieving Investigators Global Assessment (IGA) 0/1 at each scheduled visit | The IGA score ranges from 0 to 4 points, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at each scheduled visit | The IGA score ranges from 0 to 4 points, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| The average time of achieving Investigators Global Assessment (IGA) 0/1 at the atopic dermatitis (AD) target site | The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| The average time of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at the atopic dermatitis (AD) target site | The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of participants achieving at least a 3-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit | The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The Itch Numeric Rating Scale(NRS) score ranges from 0 to 10 points, higher score indicates greater intensity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion of participants achieving at least a 4-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit | The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The Itch Numeric Rating Scale(NRS) score ranges from 0 to 10 points, higher score indicates greater intensity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Change from baseline of affected Body Surface Area (BSA) at each scheduled visit | Total Body Surface Area(BSA) is 100%, and the proportion of affected BSA is ranged from 0 to100%, higher value indicates greater severity. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion of achieving Investigators Global Assessment (IGA) 0/1 in Atopic Dermatitis (AD) target site at each scheduled visit | The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear. | Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52 |
| Proportion of Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline in Atopic Dermatitis (AD) target site at each scheduled visit | The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of participants achieving Eczema Area and Severity Index(EASI) 50 at each scheduled visit | Defined as at least 50% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of participants achieving Eczema Area and Severity Index(EASI) 75 at each scheduled visit | Defined as at least 75% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of participants achieving Eczema Area and Severity Index(EASI) 90 at each scheduled visit | Defined as at least 90% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Proportion of participants achieving Eczema Area and Severity Index(EASI) 100 at each scheduled visit | Defined as at least 100% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity. | Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital |
| Principal Investigator |
| Yunsheng Liang | Dermatology Hospital of Southern Medical University | Principal Investigator |
| Wenli Feng | Second Hospital of Shanxi Medical University | Principal Investigator |
| Chao Ji | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Aie Xu | Hangzhou Third People's Hospital | Principal Investigator |
| Bingjiang Lin | First Affiliated Hospital of Ningbo University | Principal Investigator |
| Lei Cao | Brief Introduction of Wuxi No.2 People's Hospital | Principal Investigator |
| Rixin Chen | NANYANG FIRST PEOPLE'S HOSPITAL NATIONAL THIRD CLASS A HOSPITAL | Principal Investigator |
| Liming Wu | Affiliated Hangzhou First People's Hospital， School of Medicine，WestLake University | Principal Investigator |
| Yanyan Fen | Chengdu Second People's Hospital | Principal Investigator |
| Yingxia He | GENERTEC LIAOYOUGEM FLOWER HOSPITAL | Principal Investigator |
| Guoqiang Zhang | The First Hospital of Hebei Medical University | Principal Investigator |
| Meiying Jiang | Second Affiliated Hospital of Nanchang University | Principal Investigator |
| Linfeng Li | Beijing Friendship Hospital | Principal Investigator |
| Wenli Yang | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Zudong Meng | Shiyan Renmin Hospital | Principal Investigator |
| Kunpeng Bian | Nanyang Central Hospital | Principal Investigator |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |