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

NCT05891964 | Completed Phase 4

• 1 other identifier: NO.F2-81/2022-GENL/252/JPMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Secukinumab Injection; Outcome

Outcome Measures

Primary Outcomes (1)

• Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis

  Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.

  From day of randomisation until final dose of drug,assessed upto 12 months.

Secondary Outcomes (1)

• Mean difference of Psoriasis Area and Severity Index score before and after the treatment

  From day of randomisation until final dose of drug,assessed upto 12 months.

Study Arms (1)

Secukinumab

EXPERIMENTAL

Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.

Drug: Secukinumab Injection

Interventions

Secukinumab Injection DRUG

Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known plaque psoriasis
• Either gender
• Age 30-80 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Post graduate Medical centre

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Interventions

secukinumab

Study Officials

• Faiza I Siddiqui

  Jinnah post graduate Medical centre

  PRINCIPAL INVESTIGATOR

• Rabia Ghafoor

  Jinnah post graduate Medical centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: June 7, 2023
• Study Start: July 5, 2021
• Primary Completion: June 5, 2022
• Study Completion: July 10, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)