moderate to severe plaque psoriasis
Conditions
Interventions
1:Ustekinumab Injection
2:Stelara?
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 75 years; 2. Weight < 100 kg and body mass index (BMI) = 30 kg/m2; 3. Plaque psoriasis with or without psoriatic arthritis have been diagnosed at least 6 months before the first dose of the investigational product; 4. PASI = 12, PGA = 3, and BSA = 10% at screening and baseline; 5. Those who are unresponsive, contraindicated, or intolerant to any systemic treatment; 6. Subjects (including male and female subjects) have no pregnancy plan or sperm donation (egg) plan and voluntarily take effective contraceptive measures from signing informed consent to 15 weeks after the last dose of the investigational drug; 7. Subjects voluntarily participate in the trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Other types of psoriasis: erythrodermic psoriasis, pustular psoriasis, or guttate psoriasis, drug-induced psoriasis, or other skin lesions (such as eczema), which may interfere with the evaluation of the efficacy of the test drug in the treatment of psoriasis; 2) History of allergy or latex allergy to the active ingredient or any excipients of the investigational product; 3) Patients with serious, progressive or uncontrollable diseases, including but not limited to autoimmune system, cardiovascular system, blood system, respiratory system, hepatobiliary system, gastrointestinal system, endocrine system, urinary system, mental and nervous system diseases, and participation in this study will increase the risk; 4) Any of the following cardiovascular and cerebrovascular events within the first 3 months of screening: unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic angiography is allowed), heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia requiring hospitalization (such as atrial fibrillation, ventricular tachycardia, etc.), pacemaker or defibrillator implantation, transient ischemic attack or cerebrovascular events (such as stroke); or planning revascularization (e.g. coronary artery bypass grafting, etc.) in the trial; 5) Evidence of active tuberculosis (TB); 6) Known history of malignant tumors or malignant tumors (except skin basal cell carcinoma and cervical carcinoma in situ that have been cured and have no evidence of recurrence); 7) History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease; 8) Known history of recurrent or chronic infection, or can lead to chronic or recurrent infection diseases, including but not limited to: chronic obstructive pulmonary disease, chronic glomerulonephritis, etc. Recurrent urinary tract infections, open, draining, or infected wounds of the skin; 9) Received organ/tissue transplantation or stem cell transplantation; 10) Received or planned to undergo any major surgery during the study within 12 weeks prior to the first use of the investigational product; 11) Hospitalization or intravenous antibiotic treatment for serious infections (e.g., sepsis, pneumonia, pyelonephritis) within 2 months prior to screening; 12) Opportunistic infections [such as herpes zoster (severe or recurrent), active cytomegalovirus, Pneumocystis carinii, histoplasma, aspergillus, mycobacteria, etc.] within 2 months prior to screening; 13) received systemic (including oral) anti-infective drugs within 28 days before the first use of the investigational product; 14) First use of the investigational product a) Received topical treatment drugs (including not limited to corticosteroids, vitamin D analogues (calcitriol, calcitriol, methacalcidol, etc.), retinoids (retinoic acid, tazarotene, etc.), anthralin, keratinolytic agents (salicylic acid, etc.), coal tar, calcineurin inhibitors (tacrolimus, pimecrolimus, etc.), benverimod, and combinations used for topical treatment of psoriasis, etc.) within the first 2 weeks; b) Systemic drug therapy (including not limited to methotrexate, cyclosporine, etretinate (etrexetil, psoriatic acid) and altretinoin (etretinate, neopsoriatic acid), psoralen, sulfasalazine, azathioprine, mycophenolate mofetil, tacrolimus, hydroxyurea, anakinra, fumarate derivatives, or JAK inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects responding to PASI 50, PASI 75, PASI 90, PASI 100 at V3-V15 visits;Percentage of subjects achieving Psoriasis Global Assessment (PGA) (0/1) at V3-V15 visits;Percent change from baseline in PASI score at V3-V4, V6-V15 visits;Change from baseline in PGA at V3-V15 visits;Change from baseline in Body Surface Area (BSA) at V3-V15 visits;Change from baseline in Dermatology Life Quality Index (DLQI) at V3-V15 visits;Incidence and severity of Adverse events (AEs) and serious adverse events (SAEs);Anti-drug antibody (ADA) titer, incidence, and incidence of neutralizing antibody (Nab);Serum drug concentrations of ustekinumab injection and Stelara? A population pharmacokinetic (PopPK) model will be established to estimate model parameters, and explore relevant covariates affecting PK parameters; | — |
Countries
China
Contacts
Public Contactxinghua Gao
The First Hospital of China Medical University
Outcome results
None listed