THE BENEFIT OF BERMEKIMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS

Phase 1

• Conditions: CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL); MedDRA version: 20.0Level: PTClassification code 10078638Term: Systemic sclerodermaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-004655-20-GR
• Lead Sponsor: HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-31
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18 years or more
• Both genders
• In the case women of childbearing age and men, an adequate method of contraception should be used during the study. Contraception should be maintained for at least a period of 3 months after the discontinuation of treatment.
As an adequate method of contraception, it is suggested:
-male or female condom with or without spermicide
-contraceptive cap, a diaphragm or contraceptive sponge with a spermicide
Prior to admission to the study, a pregnancy test will be performed to exclude pregnancy to women of childbearing age.
• Written informed consent
• Definite classification into SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria
• Modified Rodnan Skin Score (mRSS) units more than or equal to 15 and less than 40

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients who meet ANY of the below criteria are not allowed to participate in the study:
• Age less than 18 years
• Denial to consent
• Pregnancy or lactation
• Renal crisis by SSc
• Major surgery the last 4 weeks prior to screening
• Known hypersensitivity to human, humanized, or murine monoclonal antibodies
• Active tuberculosis defined by the intake of drugs for recent tuberculosis
• Latent tuberculosis as defined by the positive interferon-? releasing assay (IGRA)
• Chronic infection by the human immunodeficiency virus (HIV)
• Any primary immunodeficiency
• Hepatic dysfunction defined as aspartate aminotransferase more than 5 times the upper normal limit (UNL) or total bilirubin more than 5 times the UNL
• Any active bacterial infection
• Active solid tumor or hematologic malignancy
• Malabsorption requiring total parenteral nutrition
• Neutropenia defined as any absolute neutrophil count lower than 1,000/mm3

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified