Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa

Early Phase 1

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Biological: Infliximab-dyyb biosimilar

• Registration Number: NCT05663268
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:

* how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa

* Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy

Detailed Description

The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:

* how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa

* Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy.

Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-23
• Primary Completion: 2023-03-30
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Patients of Hidradenitis suppurativa resistant to conventional therapy

Exclusion Criteria

• Immunocompromised patients
• Patients with connective tissue disorders
• patients having chronic infections like heapatitis, HIV or Tuberculosis
• Pregnant or lactating mothers
• hypersensitivity to biologics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients of Hidradenitis suppurativa resistant to conventional therapy	Infliximab-dyyb biosimilar	injection Infliximab-dyyb biosimilar (according to weight, single injection of 120mg if weight \<80kg, 2 injections if weight \> 80kg) will be injected subcutaneously at week 0,1, 2,3,4, and then fortnightly till 24 weeks.

Primary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI)	24 weeks	50% reduction
Hidradenitis Suppurativa Clinical Response (HiSCR)	24 weeks	50% reduction in score

Trial Locations

Locations (1)

Services Institute of Medical Sciences; 🇵🇰 Lahore, Punjab, Pakistan