Clinical trial

Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.

Name
NO.F2-81/2022-GENL/252/JPMC
Description
Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Psoriasis is phenotypically characterized by thickened, red, scaly plaques and systemic inflammation, it is also associated with multiple comorbidities, such as cardiovascular disease, stroke, hypertension, metabolic diseases, chronic kidney disease, and joint destruction. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T and dendritic cells. Inflammatory myeloid dendritic cells release interleukin (IL) 23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce psoriatic cytokines like IL-17, interferon (IFN) γ, TNF, and IL-22. These cytokines mediate the effects on keratinocytes. Secukinumab is a recombinant human monoclonal antibody that specifically binds to a proinflammatory cytokine released by T-helper-17 (Th17) cells, IL-17A. It blocks its binding with IL-17R and the expression of cytokines. This blockade normalizes the inflammatory processes and combats epidermal hyperproliferation, T-cell infiltration, and exaggerated expression of pathogenic genes.
Trial arms
Trial start
2021-07-05
Estimated PCD
2022-06-05
Trial end
2022-07-10
Status
Completed
Phase
Early phase I
Treatment
Secukinumab Injection
Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.
Arms:
Secukinumab
Other names:
Cosentyx
Size
50
Primary endpoint
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis
From day of randomisation until final dose of drug,assessed upto 12 months.
Eligibility criteria
Inclusion Criteria: * Known plaque psoriasis * Either gender * Age 30-80 years. Exclusion Criteria: * Patients with history of eczema. * Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis. * Patients with history of malignancy. * Patient with history of hepatis B, C or AIDS. * Immunocompromised patients. * Pregnant patients assessed by history and confirmed by dating scan. * Patients with history of chronic liver disease, chronic kidney disease, asthma, acute coronary syndrome, congestive heart failure and chronic obstructive pulmonary disease will be excluded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-06-07

1 organization

1 product

1 indication

Indication
Psoriasis