Plaque Psoriasis. Psoriasis vulgaris
Conditions
Interventions
Intervention 1: Intervention group: Guselkumab (CinnaGen co.) 100 mg/mL, 100 mg in each pre-filled syringe (PFS), at day 0 and weeks 4, 12, 20, 28, 36, and 44 for subcutaneous injection in the lower a
Sponsors
Cinnagen company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment based on proportion of patients with PASI 75 at week 16-PASI: Psoriasis Area Severity Index -PASI 75 means at least 75% decrease in the PASI score of the patient compared to the screening visit. Timepoint: Screening, week 16. Method of measurement: Physician assessment based on PASI questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment based on proportion of patients with PASI 100 at weeks 16 and 52- PASI 100 means a 100% decrease in the PASI score of the patient compared to the screening visit and complete recovery. Timepoint: Screening, week 16, week 52. Method of measurement: Physician assessment based on PASI questionnaire.;Response to treatment based on proportion of patients with PASI 90 at weeks 16 and 52- PASI 90 means at least 90% decrease in the PASI score of the patient compared to the screening. Timepoint: Screening, week 16, week 52. Method of measurement: Physician assessment based on PASI questionnaire.;Response to treatment based on proportion of patients with PASI 75 at week 52. Timepoint: Screening, week 52. Method of measurement: Physician assessment based on PASI questionnaire.;Response to treatment based on proportion of patients with IGA scores of 0 or 1 at weeks 16 and 52- IGA: Investigator's Global Assessment - IGA scores of 0 or 1 mean clear or almost clear of signs of psoriasis. Timepoint: Screening, week 16, week 52. Method of measurement: Physician assessment based on IGA questionnaire.;Evaluation of patients quality of life- The evaluation of patients quality of life is based on the Dermatology Life Quality Index (DLQI) questionnaire that evaluates the impact of skin conditions on quality of life from patients’ point of view. Timepoint: Screening, week 52. Method of measurement: DLQI questionnaire.;The severity of nails involvements- The severity of nails involvements is based on NAPSI (Nail Psoriasis Severity Index) score that evaluates severity and level of psoriasis affected nails. Each nail can have a 0-8 score. Timepoint: Screening, week 16, week 52. Method of measurement: Physician assessment based on NAPSI questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed