THE BENEFIT OF BERMEKIMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS

CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL) - LIGHT

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004655-20-GR

Enrollment

Registered

2019-01-31

Start date

2019-05-30

Completion date

Unknown

Last updated

2020-12-07

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

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: 20.0 Level: PT Classification code 10078638 Term: Systemic scleroderma System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: BERMEKIMAB Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Other descriptive name: BERMEKIMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a proof-of concept RCT trying to generate evidence that inhibition of IL-1a through the administration of bermekimab may inhibit progression of SSc. ;Timepoint(s) of evaluation of this end point: 24 weeks;Secondary Objective: • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the bermekimab arm • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the placebo arm • The comparison of the score of inhibition of SSc progression at week 24 between the two groups of treatment • The change of each of the 14 elements of the score of inhibition of SSc progression at week 12 between the two groups of treatment;Primary end point(s): A composite primary endpoint will be applied. This endpoint will be named “Score of inhibition of SSc progression”. A positive score will comprise at least four of the following 14 evaluation elements: • At least 30% decrease of the number of inflamed joints • At least 30% decrease of the number of digital ulcers • At least 30% decrease of the mRSS • At least 50% decrease of the UCLA GIT scoring system • At least 50% increase of the SF-36 • At least 50% decrease of VAS for SSc • At least 50% decrease of VAS for fatigue • At least 50% decrease of VAS for dyspnea • Unchanged BMI • Any increase of carbon monoxide diffusing capacity (DLCO) • Any increase of forced vital capacity (FVC) • At least 10% increase of the left ventricle ejection fraction (LVEF) • At least 10% decrease of the pulmonary artery pressure • At least 10% decrease of the capillary density as assessed by NCM Patients who stop the study drug and start another biological disease modifying anti-rheumatic drug (bDMARD) are considered to fail the primary study endpoint.	—

Measure

Time frame

Main Objective: This is a proof-of concept RCT trying to generate evidence that inhibition of IL-1a through the administration of bermekimab may inhibit progression of SSc. ;Timepoint(s) of evaluation of this end point: 24 weeks;Secondary Objective: • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the bermekimab arm • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the placebo arm • The comparison of the score of inhibition of SSc progression at week 24 between the two groups of treatment • The change of each of the 14 elements of the score of inhibition of SSc progression at week 12 between the two groups of treatment;Primary end point(s): A composite primary endpoint will be applied. This endpoint will be named “Score of inhibition of SSc progression”. A positive score will comprise at least four of the following 14 evaluation elements: • At least 30% decrease of the number of inflamed joints • At least 30% decrease of the number of digital ulcers • At least 30% decrease of the mRSS • At least 50% decrease of the UCLA GIT scoring system • At least 50% increase of the SF-36 • At least 50% decrease of VAS for SSc • At least 50% decrease of VAS for fatigue • At least 50% decrease of VAS for dyspnea • Unchanged BMI • Any increase of carbon monoxide diffusing capacity (DLCO) • Any increase of forced vital capacity (FVC) • At least 10% increase of the left ventricle ejection fraction (LVEF) • At least 10% decrease of the pulmonary artery pressure • At least 10% decrease of the capillary density as assessed by NCM Patients who stop the study drug and start another biological disease modifying anti-rheumatic drug (bDMARD) are considered to fail the primary study endpoint.

—

Secondary

Measure	Time frame
Secondary end point(s): • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the bermekimab arm • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the placebo arm • The comparison of the score of inhibition of SSc progression at week 24 between the two groups of treatment • The change of each of the 14 elements of the score of inhibition of SSc progression at week 12 between the two groups of treatment ;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Secondary end point(s): • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the bermekimab arm • The change of the achievement of a positive score of inhibition of SSc progression at week 24 compared to week 12 among patients originally allocated from week 0 to the placebo arm • The comparison of the score of inhibition of SSc progression at week 24 between the two groups of treatment • The change of each of the 14 elements of the score of inhibition of SSc progression at week 12 between the two groups of treatment ;Timepoint(s) of evaluation of this end point: 24 weeks

—

Countries

Greece

Contacts

Public ContactSECRETARY OF THE BOARD

HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

insepsis@otenet.gr00302107480662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026