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

Phase 1

Active, not recruiting

• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Biological: Infliximab-dyyb Biosimilar (Remsima)

• Registration Number: NCT06591273
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Status Verified: 2024-09
• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2024-11-05
• Study Completion: 2024-11-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult Patients of moderate to severe plaque psoriasis	Infliximab-dyyb Biosimilar (Remsima)	-

Primary Outcome Measures

Name	Time	Method
At least 50% reduction in PASI	14 weeks	PASI should reduce to at least 50% of baseline (pre-treatment)
At least 50% reduction in DLQI	14 weeks	DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment)

Secondary Outcome Measures

Name	Time	Method
Maintenance of At least 50% reduction in PASI and DLQI	52 weeks	Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)

Trial Locations

Locations (1)

Department of Dermatology, Services Institute of Medical Sciences/ Services Hospital; 🇵🇰 Lahore, Punjab, Pakistan