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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06591273

Enrollment

104

Registered

2024-09-19

Start date

2023-11-06

Completion date

2024-11-05

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

Infliximab biosimilar, Remsima, Plaque psoriasis, Biologics

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.

Interventions

BIOLOGICALInfliximab-dyyb Biosimilar (Remsima)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Maintenance of At least 50% reduction in PASI and DLQI	24 weeks	Maintenance of At least 50% reduction in PASI and DLQI from baseline (pre-treatment)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026