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This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study, all subjects need to use TQH2929 injection/placebo. The aim was to demonstrate the efficacy and safety of TQH2929 injection in patients with acute exacerbations of generalized pustular psoriasis, with a total of 36 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQH2929 Injections | Experimental | Intravenous infusion, single dose |
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| TQH2929 Placebo | Placebo Comparator | Intravenous infusion, single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQH2929 Injections | Drug | TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a score of 0 for the pustule subterm | Percentage of patients with a Physician's Global Assessment of Generalized Pustular Psoriasis (GPPGA) pustular subitem of 0 (no visible pustules) at week 1 among all enrolled patients. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) total score of 0 or 1 | Percentage of patients with a total Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 (clear) or 1 (almost clear) at weeks 1 and 4. | 1 week and 4 weeks |
| Percentage change from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Li, Doctor | Contact | 13693058190 | drlihang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospita | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| TQH2929 Placebo | Drug | Placebo contains no active substance. |
|
Percentage change from baseline in the total score of generalized pustular psoriasis area and severity index (GPPASI) at week 1 and week 4. |
| 1 week and 4 weeks |
| Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPASI) total score | Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPAS) total score at week 1 and week 4. If lower than the baseline score, indicate a certain degree of disease relief; conversely, if higher, it indicates an aggravation of the disease symptoms. | 1 week and 4 weeks |
| Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 | Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 at week 1 and week 4. | 1 week and 4 weeks |
| Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75 | Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75 at week 1 and week 4 | 1 week and 4 weeks |
| Percentage of patients with pustule subterm achieving a score of 0 | Percentage of patients with Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) pustule subterm achieving a score of 0 (no visible pustules) at week 4. | 4 weeks |
| Change from baseline in Psoriasis Symptom Scale (PSS) score | Change from baseline in Psoriasis Symptom Scale (PSS) score at week 4 | 4 weeks |
| Change from baseline in disease life quality index (DLQI) | Change from baseline in skin disease life quality index (DLQI) at week 4. If lower than the baseline score, indicate a certain degree of disease relief; conversely, if higher, it indicates an aggravation of the disease symptoms. | 4 weeks |
| Adverse Drug Event (AE) | Any untoward medical occurrence of a subject following drug treatment or exposure to an experimental factor, whether or not causally related to treatment or exposure. | 113 days or 169 days |
| Serious Adverse Event (SAE) | An event that occurs in the course of a clinical trial that results in the death of a subject or patient, serious deterioration in health, hospitalization or prolongation of hospitalization, permanent disability or loss of function, or serious consequences such as birth defects or birth defects. | 113 days or 169 days |
| Treatment-Emergent Adverse Events (TEAES) | Adverse events that occur during treatment, including from the start of treatment to a certain period of time after the end of treatment, may be directly or indirectly related to treatment. | 113 days or 169 days |
| Abnormal clinical laboratory examination indicators | Any laboratory abnormalities that occur during the test. | 113 days or 169 days |
| Time of maximum concentration (Tmax) | It refers to the time it takes for the human blood concentration curve to reach the highest concentration (peak concentration) after a single dose, measured in hours or minutes. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Maximum Concentration (Cmax) | The highest blood concentration reached after the drug is absorbed in the body. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Area Under the Curve (AUC) | It refers to the area covered by the concentration of a drug in the blood under the curve of changes over time. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Apparent Volume of Distribution(Vd/F) | When the drug reaches dynamic equilibrium in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Apparent Clearance (CL/F) | The sum of drug clearance rates of liver and kidney, etc. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Plasma half-life time (t1/2) | The time it takes for the concentration of the drug in the plasma to drop by half. | 1 hour pre-dose on day 1, immediately post dose, 1, 6, 24, 48, 168, 336, 504, 672, 1344, 2016, 2688 hours post dose. Day 8 Immediately after the end of salvage therapy administration, 1, 6, 24, 48 hours post dose |
| Anti-drug antibody (ADA) | Incidence of anti-drug antibodies (ADA) in subjects. | Through study completion, an average of half a year |
| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100191 | China |
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| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| Southern Medical University Dermatology Hospital | Not yet recruiting | Guangzhou | Guangdong | 510091 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| The Affiliated Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | 550004 | China |
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| The Second Hospital Of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The Second Affiliated Hospital of Henan University of science and technology | Not yet recruiting | Luoyang | Henan | 471000 | China |
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| Zhengzhou Central Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| The fifth Affiliated hospital of zhengzhou university | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Shiyan Renmin Hospital | Not yet recruiting | Shiyan | Hubei | 442000 | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430060 | China |
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| The First Hospital of Hunan University of Chinese Medicine | Not yet recruiting | Changsha | Hunan | 410007 | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| The General Hospital Of Hunan University Of Medicine | Not yet recruiting | Huaihua | Hunan | 41800 | China |
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| The first hospital of jilin university | Not yet recruiting | Changchun | Jilin | 130012 | China |
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| The first hospital of china medical university | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Shandong First Medical University Affiliated Dermatology Hospital | Not yet recruiting | Jinan | Shandong | 250022 | China |
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| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200443 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
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| Chengdu Second People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Sichuan Provincial People' s Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300120 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang | 830001 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830013 | China |
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| The First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| Jiaxing First Hospital | Not yet recruiting | Jiaxing | Zhejiang | 314001 | China |
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| The first affiliated hospital of ningbo university | Not yet recruiting | Ningbo | Zhejiang | 315020 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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