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NCT Number: NCT06591273

Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial

The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:

Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?

Participants will:

be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Dermatology, Services Institute of Medical Sciences/ Services Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Patients of moderate to severe plaque psoriasis Biologically naive patients

Exclusion criteria

  • Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.

Treatment and study plan

Infliximab-dyyb Biosimilar (Remsima)

Biological

Subcutaneous injections of Infliximab-dyyb Biosimilar (Remsima) were injected weekly for 4 weeks and then fortnightly for 24 weeks

Primary outcomes

  1. At least 50% reduction in PASI

    Time frame: 14 weeks

    PASI should reduce to at least 50% of baseline (pre-treatment)

  2. At least 50% reduction in DLQI

    Time frame: 14 weeks

    DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment)

Secondary outcomes

  1. Maintenance of At least 50% reduction in PASI and DLQI

    Time frame: 24 weeks

    Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)

  2. Maintenance of At least 50% reduction in PASI and DLQI

    Time frame: 52 weeks

    Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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