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This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis.
The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: SHR0302 dose A | Active Comparator | Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. |
|
| Active Comparator: SHR0302 dose B | Active Comparator | Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. |
|
| Placebo Comparator: Placebo | Active Comparator | Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: SHR0302 | Drug | The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline. | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Czema Area and Severity Index (EASI) Change. | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). | Up to week 12 |
| Percentage of Subjects Achieving Investigator's Global Score (IGA) Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Xicheng | Beijing Municipality | China | |||
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34374027 | Derived | Zhao Y, Zhang L, Ding Y, Tao X, Ji C, Dong X, Lu J, Wu L, Wang R, Lu Q, Goh AH, Liu R, Zhang Z, Zhang J. Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial. Am J Clin Dermatol. 2021 Nov;22(6):877-889. doi: 10.1007/s40257-021-00627-2. Epub 2021 Aug 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: SHR0302 Dose A | Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
| FG001 | Active Comparator: SHR0302 Dose B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2019 | Jun 28, 2022 |
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The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. |
| Up to week 8 |
| Percent of Pruritus Numerical Rating Scale (NRS) Change | The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period. | Up to week 12 |
| Tianjin |
| Tianjin Municipality |
| 300120 |
| China |
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China |
| Peking University Third Hospital | Beijing | 100083 | China |
| Peking union medical college hospital | Beijing | 100730 | China |
| Beijing Tsinghua Changgeng Hospital | Beijing | 102218 | China |
| The Second Xiangya Hospital of Central South University | Changsha | 410008 | China |
| Xiangya Hospital of Central South University | Changsha | 410008 | China |
| The Third Xiangya Hospital of Central South University | Changsha | 410013 | China |
| Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Chongqing | 400037 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | 350005 | China |
| Guangdong Provincial People's Hospital | Guangzhou | 510000 | China |
| Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University | Guangzhou | 51000 | China |
| The first affiliated hospital Zhejiang university | Hangzhou | 310003 | China |
| Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine | Hangzhou | 310006 | China |
| Zhejiang province People's Hospital | Hangzhou | 310014 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| Shanghai Skin Disease Hospital | Shanghai | 200050 | China |
| The first hospital of China medical university | Shenyang | 110001 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
| The First Hospital of Shanxi Medical University | Taiyuan | 030001 | China |
| Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Henan provincial people's hospital | Zhengzhou | 450003 | China |
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
| FG002 | Placebo Comparator: Placebo | Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: SHR0302 Dose A | Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
| BG001 | Active Comparator: SHR0302 Dose B | Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
| BG002 | Placebo Comparator: Placebo | Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Disease duration | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline. | Posted | Count of Participants | Participants | At week 12 |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Czema Area and Severity Index (EASI) Change. | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). | Not Posted | Up to week 12 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving Investigator's Global Score (IGA) Response | The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. | Not Posted | Up to week 8 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Pruritus Numerical Rating Scale (NRS) Change | The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period. | Not Posted | Up to week 12 | Participants |
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: SHR0302 Dose A | Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 0 | 35 | 2 | 35 | 13 | 35 |
| EG001 | Active Comparator: SHR0302 Dose B | Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 0 | 35 | 1 | 35 | 16 | 35 |
| EG002 | Placebo Comparator: Placebo | Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 0 | 35 | 0 | 35 | 10 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Tri-iodothyronine free increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Liu, Medical Director | ReistoneBiopharma | 8613917512446 | roger.liu@reistonebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2020 | Jun 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
|