TQH2929 Injections
DrugTQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
NCT Number: NCT07314060
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Peking University First Hospita, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
Placebo contains no active substance.
Time frame: 1 week
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.
Time frame: 1 week and 4 weeks
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.
Time frame: 1 week and 4 weeks
Percentage change from baseline in the total score of generalized pustular psoriasis area and severity index (GPPASI) at week 1 and week 4.
Time frame: 1 week and 4 weeks
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.
Time frame: 1 week and 4 weeks
Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 at week 1 and week 4.
Time frame: 1 week and 4 weeks
Percentage of patients who achieved Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75 at week 1 and week 4
Time frame: 4 weeks
Percentage of patients with Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) pustule subterm achieving a score of 0 (no visible pustules) at week 4.
Time frame: 4 weeks
Change from baseline in Psoriasis Symptom Scale (PSS) score at week 4
Time frame: 4 weeks
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.
Time frame: 113 days or 169 days
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.
Time frame: 113 days or 169 days
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.
Time frame: 113 days or 169 days
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.
Time frame: 113 days or 169 days
Any laboratory abnormalities that occur during the test.
Time frame: 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
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.
Time frame: 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
The highest blood concentration reached after the drug is absorbed in the body.
Time frame: 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
It refers to the area covered by the concentration of a drug in the blood under the curve of changes over time.
Time frame: 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
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.
Time frame: 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
The sum of drug clearance rates of liver and kidney, etc.
Time frame: 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
The time it takes for the concentration of the drug in the plasma to drop by half.
Time frame: Through study completion, an average of half a year
Incidence of anti-drug antibodies (ADA) in subjects.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of TQH2929 Injection in Patients With Acute Exacerbations of Generalized Pustular Psoriasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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