Efficacy of Injection Sekucinumab in Erythrodermic Psoriasis

NCT06801028 | Not Yet Recruiting

• 1 other identifier: NO.F.2-81/2024-GENL/137/JPMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Erythroderma is a rare and severe dermatological manifestation of a variety of diseases. The most common form of erythroderma is erythrodermic psoriasis (EP), which accounts for 1-2.25% of all psoriatic patients, with a male predominance as demonstrated by a male to female ratio of 3:1. EP clinically manifests with diffuse erythema involving also skin folds with or without exfoliate dermatitis. Secukinumab is a FDA approved biological targeting interleukin-17A (IL17A) cytokine used in the treatment of moderate-to-severe psoriasis. Many clinical trials have been undertaken to establish its efficacy and safety in psoriasis. Numerous studies have highlighted the efficacy and safety of secukinumab. Secukinumab yields rapid and sustained improvements of signs and symptoms in patients EP. Secukinumab also had the lowest treatment cost compared with other biologic treatments for moderate to severe psoriasis. Secukinumab is a monoclonal antibody targeting IL-17, a key player in psoriasis pathogenesis, making it highly effective for psoriasis management. Erythrodermic psoriasis (EP) is a rare, severe form of the disease, affecting over 90% of the body, with significant health risks like electrolyte imbalance and infection. Treatment options for EP are not standardized due to its rarity, and conventional therapies such as acitretin, ciclosporin, and methotrexate have limited efficacy and tolerance issues. While biologics are well-studied for plaque psoriasis, data on EP is scarce. This study aims to evaluate secukinumab's efficacy in EP and explore factors influencing treatment outcomes.

Conditions

Erythrodermic Psoriasis

Keywords

Erythrodermic Psoriasis; Efficacy; Sekucinumab

Outcome Measures

Primary Outcomes (1)

• Efficacy (Psoriasis Area Severity Index (PASI) Score)

  The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. The Psoriasis Area Severity Index (PASI) Calculator (1.7.3) (https://pasi.corti.li/ ) or manual working sheet https://www.huidziekten.nl/pdf/PASI-Psoriasis-Area-and-Severity-Index.pdf.) will be utilized to calculate the PASI score at each time interval. Efficacy assessment will be performed by measuring change in PASI score from baseline. PASI-75 (75% or greater improvement/ 75% or more reduction in PASI score) will be considered as efficacy of treatment. It will be assessed after treatment induction (Week 4) at 4, 8, 12, 16 and 20 week.

  20th week

Study Arms (1)

Erythrodermic Psoriasis

Erythrodermic Psoriasis will be treated by injection Sekucinumab

Biological: injection Sekucinumab

Interventions

injection Sekucinumab BIOLOGICAL

All patients with erythrodermic psoriasis (EP), who will receive subcutaneous injection of secukinumab at a dose of 300 mg once a week from week 0 to 4 followed by every 4 week. At weeks 0, 4, 8, 12, 16 and 20 the psoriasis area and severity index (PASI) will be recorded and adverse drug reactions, patient's satisfaction and recurrence will be observed.

Erythrodermic Psoriasis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EP Patients presenting with the histological and/or clinical manifestations (Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch) on more than 90% of body surface area.

You may qualify if:

• Patients of age 18-65 years age.
• Either sex.
• Patients presenting with the clinical manifestations of Erythrodermic Psoriasis such as redness, inflammation, skin rash, erythema, scaling, and itch on more than 90% of body surface area.

You may not qualify if:

• Patients of pediatric age.
• Erythroderma caused by a condition other than psoriasis.
• Patient treated with biologics for a different condition other than EP.
• Diabetic, immunocompromised patients.
• Women with pregnancy or lactating mothers.
• Patients allergic to the drugs in this study.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Department of Dermatology Jinnah Postgraduate Medical Center (JPMC), Karachi

Karachi, Sindh, 22557, Pakistan

Location

Study Officials

• Maria Iqbal, MBBS, FCPS Trainee

  JPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Iqbal, MBBS, FCPS Trainee

CONTACT

00923001057555; mariashaikh140@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator, MBBS, FCPS Trainee

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 30, 2025
• Study Start: January 20, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)