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

NCT06591273 | Active Not Recruiting Phase 1

• 1 other identifier: IRB/2023/1201/SIMS
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

Infliximab biosimilar, Remsima, Plaque psoriasis, Biologics

Outcome Measures

Primary Outcomes (2)

• At least 50% reduction in PASI

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

  14 weeks

• At least 50% reduction in DLQI

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

  14 weeks

Secondary Outcomes (2)

• Maintenance of At least 50% reduction in PASI and DLQI

  24 weeks

• Maintenance of At least 50% reduction in PASI and DLQI

  52 weeks

Study Arms (1)

Adult Patients of moderate to severe plaque psoriasis

EXPERIMENTAL

Biological: Infliximab-dyyb Biosimilar (Remsima)

Interventions

Infliximab-dyyb Biosimilar (Remsima) BIOLOGICAL

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

Adult Patients of moderate to severe plaque psoriasis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

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

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Interventions

CT-P13

Study Officials

• Dr Hira Tariq, MBBS, FCPS Derma

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: November 6, 2023
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

PA (1)