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

NCT ID: NCT06591273

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate to Severe Chronic Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult Patients of moderate to severe plaque psoriasis

Group Type EXPERIMENTAL

Infliximab-dyyb Biosimilar (Remsima)

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infliximab-dyyb Biosimilar (Remsima)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hira Tariq

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr Hira Tariq, MBBS, FCPS Derma

Role: PRINCIPAL_INVESTIGATOR

Services Institute of Medical Sciences, Lahore

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB/2023/1201/SIMS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.