NCT06591273

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Services Institute of Medical Sciences, Pakistan · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

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

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-11-05
• Completion: 2024-11-05
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Pakistan