Plaque Psoriasis
Conditions
Interventions
A:The patients will receive infusions of HS626 5 mg/kg at weeks 0,2,6,14,22,30,38,46.
B:The patients will receive infusions of Remicade 5 mg/kg at weeks 0,2,6,14,22,30,38,46.
Sponsors
The Second Affiliated hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject voluntarily signed informed consent and could be reliable and capable of adhering to the protocol; 2. Aged 18 to 75 years at the date of signature of the informed consent; 3. BMI:18~32kg/m2; 4. A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months; 5. Subject has a stable history of plaque psoriasis for at least 2 months before randomization according to the judgment of the Investigator; 6. Subject has moderate to severe psoriasis at screening and baseline, as defined below: Psoriasis Area and Severity Index (PASI) score >=12 (0-72), and Body Surface Area (BSA) affected by psoriasis >=10 %; 7. Study participant must be a candidate for systemic therapy. Defined as moderate to severe chronic plaque type with poor control through local and / or phototherapy and / or previous traditional systemic treatment Psoriasis subjects (including insensitivity to the original treatment, or intolerance, or contraindications, or treatment failure).
Exclusion criteria
Exclusion criteria: 1. Patients have nonplaque forms of psoriasissuch as pustular psoriasis, erythrodermic psoriasis, guttate psoriasis; 2. Patients have a history of drug-induced psoriasis (including but not limited to new psoriasis or exacerbations of psoriasis caused by beta blockers, calcium channel inhibitors or lithium); 3. Patients who are allergic to any of the components of the investigational medicinal product, or patients who have previously had an allergic reaction to drugs of the same pharmacological and biological classification; 4. Patients who used UVB within 2 weeks or Psoralen + UVA (PUVA) within 4 weeks before randomization; 5. Patients who used local treatment within 2 weeks before randomization, including glucocorticoids, vitamin D derivatives, retinoic acid preparations, etc.; 6. Patients had systemic treatment for psoriasis within 4 weeks before randomization; 7. Patients used biologics, such as inhibitor of TNF-alpha/ IL-6R/ IL-12/ IL-23/ IL-17, within 12 weeks before randomization; 8. Subjects who received any live vaccine within 2 months before randomization or plan to receive any vaccine during the study period; 9. Patients who have previously been treated with infliximab, or those with positive anti-drug antibody results during the screening period; 10. Participants who are pregnant or nursing; 11. Patients have other active inflammatory diseases that may confuse treatment evaluations; 12. Patients have medical, psychiatric condition or a history of mental illness, that is currently unsuitable for the trial or the investigator believes will impact the compliance; 13. Patients with severe, progressive, or uncontrolled disease. The participation in the study will increases the risk. Including but not limited to: (1) History of myocardial infarction within 12 months before signing informed consent; (2) Unstable angina pectoris; (3) Congestive heart failure (NYHA III or IV); (4) Severe lung disease that requires hospitalization or oxygen therapy, such as chronic bronchitis, obstructive pulmonary disease; 14. Patients had history of lymphoproliferative disease, or any malignancy, or any organ system malignancy in the past 5 years; 15. Patients are suffering from persistent or chronic active infection, and is not suitable for participation in the study at the discretion of the investigator; Patients had severe infections requiring systemic anti-infective treatment or hospitalization within 4 weeks before randomization; 16. Patients have active tuberculosis or the history of tuberculosis, or a chest radiograph suggesting a previous infection with tuberculosis, or a positive ?-interferon release test; 17. Patients have human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus antibody, or hepatitis B surface antigen. When hepatitis B surface antigen is negative and core antibody is positive, patient should be tested for hepatitis B virus DNA, if it is greater than or equal to the upper limit of this hospital's reference value, the patient should be excluded; 18. Patients have abnormal laboratory test results. Any results of laboratory tests that investigators consider clinical significance, the patient is not suitable to participate in this trial. 19. Patients had central nervous system demyelinating disease (such as multiple sclerosis or optic neuritis) or suspected central nervous system demyelinating disease; 20. Patients are unable or unwilling to undergo repeated venipunctur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 30.;Proportion of patients achieving a = 50% improvement in PASI score from baseline at week 10, 30 and 52.;Proportion of patients achieving a = 90% improvement in PASI score from baseline at week 10, 30 and 52.;Proportion of subjects with improved overall physician assessment (PGA) scores from baseline (scores reduced to 0 or 1) at weeks 10, 30, and 52.;The proportion of subjects who had a PGA score that had subsided (reduced to 0) from baseline at weeks 10, 30, and 52.;At 10, 30, and 52 weeks, the skin quality of life (DLQI) score improved from baseline.;Degree of change in rash area (BSA) from baseline at weeks 10, 30 and 52.; | — |
Countries
China
Contacts
Public ContactMin Zheng
The Second Affiliated Hospital of Zhejiang University Medical College
Outcome results
None listed