Generalized Pustular Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGTQH2929 Injections
TQH2929 is a humanized monoclonal antibody that interfering with the signal cascade.
DRUGTQH2929 Placebo
Placebo contains no active substance.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 or ≤75 years old at screening, regardless of gender; * Meet the diagnostic criteria defined by the 2017 European Society for Clinical Nutrition and Metabolism (ESPEN) Research Workshop (ERASPEN) consensus and be diagnosed as （generalized pustular psoriasis(GPP); * Compliant with GPP acute onset; * Able to read and understand, and willing to sign the informed consent form; * Willing and compliant with study visits and related procedures; * Female subjects of childbearing age should agree that contraceptive measures must be used during the study and for 6 months after the end of the study;
Exclusion criteria
* Pustules are limited to psoriasis vulgaris on psoriasis plaques; * Concomitant skin disease or medical disease that may interfere with the investigator's evaluation of the subject's treatment response; * Presence of severe, progressive, or uncontrolled disease, or signs and symptoms that are not suitable for participation in the investigator, in the judgment of the investigator: * Serum virological abnormalities during the screening period; * Chest radiology examination shows that the subject has active tuberculosis or a history of contact with open tuberculosis subjects in the past 6 months or a positive Interferon-Gamma Release Assays(IGRA) test; * History of serious infection leading to hospitalization within 2 months prior to baseline; * Active infection requiring systemic antibiotics, systemic antifungals, or systemic antiviral therapy within 2 weeks prior to baseline, according to the investigator's assessment; * History of opportunistic infection within 6 months prior to baseline; * Received live (attenuated) vaccine treatment within 12 weeks prior to baseline; * Any major surgery within 4 weeks prior to baseline or planned major surgery during the study; * Received blood transfusion within 4 weeks prior to baseline; * Participated in clinical trials of other drugs or medical devices within 4 weeks before baseline; * Any known or suspected congenital or acquired immunodeficiency state or condition that may compromise the subject's immune status; * Subjects with any type of active malignancy or a history of malignancy; * Alcohol, drug and known drug dependence; * Pregnant or lactating women; * Subjects cannot tolerate intravenous infusion administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a score of 0 for the pustule subterm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA) total score of 0 or 1 | 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. |
| Percentage change from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) total score | 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. |
| Change from baseline in Generalized Pustular Psoriasis Area and Severity Index(GPPASI) total score | 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. |
| Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 50 | 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. |
| Percentage of patients with Generalized Pustular Psoriasis Area and Severity Index(GPPASI) 75 | 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 |
| Percentage of patients with pustule subterm achieving a score of 0 | 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. |
| Change from baseline in Psoriasis Symptom Scale (PSS) score | 4 weeks | Change from baseline in Psoriasis Symptom Scale (PSS) score at week 4 |
| Change from baseline in disease life quality index (DLQI) | 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. |
| Adverse Drug Event (AE) | 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. |
| Serious Adverse Event (SAE) | 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. |
| Treatment-Emergent Adverse Events (TEAES) | 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. |
| Abnormal clinical laboratory examination indicators | 113 days or 169 days | Any laboratory abnormalities that occur during the test. |
| Time of maximum concentration (Tmax) | 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. |
| Maximum Concentration (Cmax) | 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. |
| Area Under the Curve (AUC) | 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. |
| Apparent Volume of Distribution(Vd/F) | 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. |
| Apparent Clearance (CL/F) | 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. |
| Plasma half-life time (t1/2) | 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. |
| Anti-drug antibody (ADA) | Through study completion, an average of half a year | Incidence of anti-drug antibodies (ADA) in subjects. |
Countries
China
Outcome results
None listed