Plaque psoriasis
Conditions
Interventions
GR1501 injection treatment group:GR1501 injection
placebo:placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-70 years; 2. Patients diagnosed with chronic plaque psoriasis had a history of psoriasis at least 6 months at baseline; 3. Screening and baseline patients with psoriasis surface area (BSA) >= 10%; 4. The subjects with PGA >= 3 and PASI >= 12 at baseline were screened; 5. Patients with moderate or severe plaque psoriasis who are treated regularly but with poor effect; 6. Female subjects had no fertility or egg donation plan from the screening period to 6 months after the end of the last administration and voluntarily took effective physical contraceptive measures, while male subjects had no fertility or sperm donation plan from the screening period to 6 months after the end of the last administration and voluntarily took effective physical contraceptive measures; 7. Volunteers who signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with pustular psoriasis, erythrodermic psoriasis and / or topical psoriasis at screening or baseline; 2. Patients with drug-induced psoriasis at baseline; 3. Patients with other inflammatory diseases, including but not limited to: inflammatory bowel disease, uveitis, atopic dermatitis, etc., which may affect the efficacy and safety evaluation according to the judgment of researchers; 4. Patients with severe autoimmune diseases, including but not limited to: systemic sclerosis, systemic lupus erythematosus, etc., which may affect the efficacy and safety evaluation according to the judgment of researchers; 5. Before baseline, subjects received the following treatments: (1) Received systemic anti psoriasis drugs (including traditional Chinese medicine, Chinese patent medicine, etc.) within 4 weeks before baseline; Those who had received cyclosporine treatment within 8 weeks before baseline were not included in the study; (2) They had received local anti psoriasis drugs (including traditional Chinese medicine, Chinese patent medicine, etc.) within 2 weeks before baseline; (3) Physical therapy (including photochemical therapy, ultraviolet therapy, sunbathing self-treatment, etc.) was used within 4 weeks before baseline; 6. Subjects who recently used the following biological agents or their biological analogues: before baseline, etanercept < 28 days; Infliximab, adalimumab or afacetate < 60 days; Golimumab < 90 days; Rituximab or leucozumab < 12 months; Or all other biological agents < 5 half lives; 7. Subjects who have received any drugs directly targeting IL-17 or IL-17 receptor, or IL-12 / IL-23, or IL-23; 8. Subjects who have participated in clinical trials of other drugs within 3 months before baseline, or whose test drugs are still within 5 half lives before baseline; 9. Subjects who had been vaccinated with live vaccine within 8 weeks before baseline, or were willing to receive live vaccine during the study period; 10. Subjects with active tuberculosis indicated by clinical symptoms, physical signs, laboratory examination, CT examination or medical history were screened; Patients with latent tuberculosis infection (after preventive treatment with isoniazid 0.3g QD for at least 4 weeks, and after re assessment by researchers, the risk can be controlled, they can continue to be selected into the group); 11. Subjects who have a history of allergy to two or more drugs or severe allergy or allergy to biological products, or who may be allergic to the test drug or any component in the test drug according to the judgment of the researcher; 12. Subjects who had undergone major surgery within 8 weeks before baseline or who will need to undergo such surgery during the study period; 13. Patients with history of lymphoproliferative diseases were inquired; Or currently suffering from malignant tumor or have a history of malignant tumor; 14. Subjects with active infection or history of disease, and the risk of the subjects was determined uncontrollable after the evaluation of the researchers; 15. Subjects with previous or current severe herpes virus infection; 16. Subjects with positive HBsAg and HBcAg (except those whose HBV DNA copy number is lower than the lower limit of detection); Hepatitis C antibody, human immunodeficiency virus (HIV) antibody and anti Treponema pallidum antibody (TP AB) were positive (except RPR or trust negative); 17. ECG abnormalities with clinical significance and causing unacceptable risk t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI75;Proportion of subjects achieving PGA (0~1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI75, PASI90, PGA (0~1);PASI score improvement;Safety evaluation indicators (adverse events, laboratory examinations, vital signs, electrocardiogram examination, physical examination, Columbia-Suicide Severity Rating Scale (C-SSRS);ADA;pk;Dermatological Quality of Life Index (DLQI) score;Improvement of NRS score of severity of itching;Recurrence throughout the trial period and rebound after the last dose; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed