Inclusion criteria:
Male or female between 18 to 75 years of age (inclusive).
Have a diagnosis of plaque-type psoriasis, with or without psoriatic arthritis, for at least 6 months before the first administration of the study intervention.
Have an involved BSA (Body Surface Area) at least 10 percent at screening.
Have a PASI (Psoriasis Area Severity Index) at least 12 at screening.
Have an IGA (Investigator's Global Assessment) at least 3 at screening.
Be a candidate for systemic treatment for plaque psoriasis
Inadequate response in case of treatment with adalimumab, golimumab, infliximab, anakinra, or etanercept.(In this condition, these treatments should have been discontinued before specific durations prior to the first administration of the study intervention:- Adalimumab, golimumab, infliximab, or anakinra at least 4 weeks before the first administration of the study intervention.- Etanercept at least 2 weeks before the first administration of the study intervention).
Ability to comprehend and willingness to sign the informed consent form for this study.
Exclusion criteria:
Has a history or current signs or symptoms of severe, progressive, or uncontrolled medical conditions due to the investigator’s opinion.
Has other autoimmune diseases (e.g, inflammatory bowel disease, etc.)
Has a transplanted organ (with the exception of a corneal transplant at least 3 months before the first administration of study intervention).
Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in this study and within 12 weeks following the last administration of the study intervention.
Has a nonplaque form of psoriasis (e.g., erythrodermic, guttate, or pustular).
Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
Has had major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or will not be fully recovered from such surgery, or has such surgery planned during the time the subject is expected to participate in the study (52 weeks).(Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.)
Is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months prior to screening due to investigator’s opinion.
Has hypersensitivity, allergies, or known intolerance to the formulation, or known allergy or sensitivity to latex.
Has previously received guselkumab.
Has received any therapeutic agent directly targeted to IL-12, IL-17A, IL-17R, or IL-23 within 6 months prior to the first administration of study intervention (including but not limited to ustekinumab, tildrakizumab, risankizumab, ixekizumab, brodalumab, or secukinumab.)IL: Interleukin
Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months prior to the first administration of study intervention.
Has received any systemic immunosuppressants (e.g., methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, or JAK (Janus Kinase) inhibitors) within 4 weeks of the first administration of study intervention
Has received phototherapy or any systemic medications/treatments (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 or analogues, psoralens, sulfasalazine, hydroxyurea, apremilast, fumaric acid derivatives) or any systemic or topical herbal treatments or traditional medicines that could affect psoriasis within 4 weeks of the first administration of study intervention.
Is currently receiving lithium, antimalarials, or intramuscular (IM) gold, or has received lithium, antimalarials, or IM gold within 4 weeks of the first administration of the study intervention.
Has received any investigational agent within 30 days or passing less than 5 half-lives of the investigational agent (whichever is longer) of the first administration of the study intervention or participating in clinical studies consisting of any investigational agent or procedure.
Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of the study intervention.
Having hepatitis B, hepatitis C, or HIV (Human Immunodeficiency Virus) infection.
Abnormal laboratory tests at the screening, including:- GFR (Glomerular Filtration Rate) less than 30 mL/min (Mililitter per Minute) (based on Cockcroft-Gault Equation)- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels more than100 IU/L (International Units Per Liter)Note: Patients with hepatic enzymes (AST or ALT) of at least 70 IU/L up to maximum 100 IU/L at the screening, need a hepatologist's approval for the study enrollment.- Total bilirubin or alkaline phosphatase (ALP) at least 3 × ULN (Upper Limit of Normal)Note: Patients with total bilirubin or ALP greater or equal to 2 up to 3 × ULN at the screening, need a hepatologist's approval for the study enrollment.- Hemoglobin less than 8 g/dL (Grams per Decilitre)- Platelet less than 100 × 103/µL (Microlitter)- Neutrophil less than 1.5 × 103/µL- WBC (White Blood Cells) less than 3.5 × 103/µL
Tuberculosis (TB) assessment with PPD (Purified Protein Derivative) more than 5mm or positive IGRA (Interferon-Gamma Release Assay).Note: Patients who have received complete treatment for latent TB prior to enrolling the study can participate.
Has or has had a serious infection or has been hospitalized or received injectable antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to the first administration of the study intervention.
Has or has had herpes zoster within 2 months before the screening.
Currently has a known malignancy or has a history of malignancy.
Having any other condition which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study or that could prevent, limit, or confound the protocol-specified assessments.