Moderate-to-severe plaque psoriasis
Conditions
Interventions
Guselkumab 100 mg SC and Placebo:receive Guselkumab 100 mg injection
Sponsors
The Second Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. 18 years old (including 18 years old) or above. Subject type and disease characteristics; 2. Plaque psoriasis (with or without PsA) was diagnosed at least 6 months before screening; 3. Screening and baseline disease criteria are within the following parameters: 1) PASI=12 2) IGA=3 3) Affected BSA = 10%; 4. It is suitable for phototherapy or systemic treatment of psoriasis (whether it is primary treatment or has a history of previous treatment), gender and contraceptive/barrier contraceptive requirements; 5. Male or female; 6. Before the first administration of the study drug, female subjects must: 1) Non-fertility: premenopausal, menopausal (over 45 years old and amenorrhea for at least 12 months, or for any age, amenorrhea for at least 6 months and serum follicle-stimulating hormone [FSH] level>40IU/L); Permanent sterilization (e.g. fallopian tube obstruction, hysterectomy, bilateral fallopian tube resection); Or there are other conditions that prevent pregnancy. 2) Have fertility but take effective contraceptive measures, and the contraceptive measures must comply with the provisions of local laws and regulations on the contraceptive measures used by subjects participating in clinical research: such as oral, injection or hormone implantation; Implantation of intrauterine device (IUD) or intrauterine device system (IUS); Barrier method: condom or sealing cap (diaphragm or cervix/dome cap) containing spermicidal foam/gel/film/cream/suppository; Male partner sterilization (the partner who has undergone vasectomy must be the only partner of the subject); Complete abstinence (used when this practice is consistent with the subject's preferences and normal lifestyle). Note: If the fertility changes after the start of the study (for example, women who have no heterosexual sex become heterosexual, or women who have menarche in premenstrual period), women must start to take 2 kinds of effective contraceptive measures, at least one of which must be barrier method, as described above. 7. The urine pregnancy test of fertile women at screening and baseline must be negative. 8. Female subjects must agree not to donate eggs (oocytes, oocytes) or freeze eggs for assisted reproductive purposes during the study period and within 12 weeks after the last administration of the study drug. 9. Men who have sex with fertile women and have not undergone vasectomy must agree to use two effective contraceptives during the study period and within 12 weeks after the last administration of the study drug, at least one of which must be the barrier method described in inclusion criteria 6. All males must also agree not to donate sperm during the study and within 12 weeks after the last administration of the study drug. Infectious diseases related inclusion criteria; 10. Select qualified subjects according to the following TB criteria: 1) There was no history of latent or active TB before screening. Except for the subjects who are currently receiving latent TB treatment but have no evidence of active TB, or those who have a history of latent TB and have records showing that they have completed appropriate treatment of latent TB within 5 years before screening. Researchers are responsible for verifying the adequacy of previous anti-tB treatment and providing appropriate data. 2) According to the medical history and/or the results of physical examination, there are no signs or symptoms indicating active TB. 3) No close contact with active TB patients
Exclusion criteria
Exclusion criteria: 1. Nonplaque psoriasis (such as erythrodermic type, droplet type or pustular type); 2. There are currently drug-induced psoriasis (e.g ß Caused by receptor blockers, calcium channel blockers or lithium therapy New psoriasis or aggravation of psoriasis); Coexisting medical conditions or past medical history; 3. Have a history of liver or renal insufficiency or current liver or renal insufficiency (estimated creatinine clearance rate is less than 60 ML/min); Significant, progressive or uncontrolled heart, blood vessel, lung, gastrointestinal tract Endocrine, nervous, blood, rheumatism, mental or metabolic disorders; 4. Unstable cardiovascular disease is defined as clinical deterioration (such as unstable angina pectoris) in the past 3 months Pain, atrial fibrillation) or hospitalization due to heart disease within 3 months before screening; 5. Have undergone organ transplantation (except corneal transplantation more than 3 months before the first administration of the study drug); 6. Have a history of infection of artificial joint, or have received antibiotic treatment due to suspected infection of artificial joint, Provided that the artificial joint is not removed or replaced; 7. Pregnant, breast-feeding or planned at the time of enrollment in the study or within 12 weeks after the last administration of the study intervention drug Pregnancy (male and female); 8. Known hypersensitivity, hypersensitivity or intolerance to Guseczumab or its excipients (see Guseczumab IB) [Guseczumab IB 2020]; 9. Known intolerance or hypersensitivity to any biological agent drug, or known resistance to mouse, chimeric or human origin Allergies or clinically significant reactions to chemoproteins, monoclonal antibodies or antibody fragments; 10. According to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, there was a history of drug or alcohol abuse within one year before screening. Increased risk of malignancy or malignancy; 11. Currently suffering from malignant tumor or having a history of malignant tumor within 5 years before screening (but sufficient treatment and research are allowed Investigate the non-melanoma skin cancer with no evidence of recurrence at least 3 months before the first administration of the drug, have received treatment and Cervical carcinoma in situ without evidence of recurrence at least 3 months before screening or malignant tumor that has been cured and has a very low risk of recurrence Tumor patient enrollment study); 12. Have a history of lymphoproliferative diseases, including lymphoma; Unidentified monoclonal gammaglobulin disease (MGUS) history; Or suggest that there may be signs and symptoms of lymphoproliferative diseases, such as lymph nodes Disease and/or splenomegaly; Infection or susceptible factors of infection; 13. Have suffered or are suffering from chronic or recurrent infectious diseases, including but not limited to recurrent pulmonary infection, bronchi Dilation, recurrent renal/urinary tract infection (e.g., recurrent pyelonephritis, recurrent cystitis), fungal infection Infection (mucocutaneous candidiasis), open wound, wound suppuration, wound infection or ulcer; 14. There is a history of latent or active granulomatous infection before screening, including histoplasmosis or coccidiosis Bacterial disease. For information about the eligibility of latent TB history, see inclusion criteria 10; 15. Take chest radiographs (which can replace chest CT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI;IGA; | — |
Countries
China
Contacts
Public ContactWei Yan
Outcome results
None listed