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

Services Institute of Medical Sciences, Pakistan

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Moderate to Severe Chronic Plaque Psoriasis

Treatments: Biological: Infliximab-dyyb Biosimilar (Remsima)

Study type: Interventional

Funder types: Other

Identifiers

NCT06591273

IRB/2023/1201/SIMS

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Adult Patients of moderate to severe plaque psoriasis

Experimental group

Treatment:

Biological: Infliximab-dyyb Biosimilar (Remsima)