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

NCT05663268 | Completed Early Phase 1

• 1 other identifier: IRB/2022/101/SIMS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa; Infliximab biosimilar; Efficacy; safety

Outcome Measures

Primary Outcomes (2)

• Hidradenitis Suppurativa Clinical Response (HiSCR)

  50% reduction in score

  24 weeks

• Dermatology Life Quality Index (DLQI)

  50% reduction

  24 weeks

Study Arms (1)

Patients of Hidradenitis suppurativa resistant to conventional therapy

EXPERIMENTAL

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.

Biological: Infliximab-dyyb biosimilar

Interventions

Infliximab-dyyb biosimilar BIOLOGICAL

Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.

Also known as: Remsima (infliximab-dyyb biosimilar)

Patients of Hidradenitis suppurativa resistant to conventional therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of Hidradenitis suppurativa resistant to conventional therapy

You may not qualify if:

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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.

  PMID: 17587838 RESULT

• Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003 Nov;149(5):1046-9. doi: 10.1111/j.1365-2133.2003.05663.x.

  PMID: 14632813 RESULT

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

CT-P13

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Hira Tariq, FCPS Derma

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: October 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

PA (1)