EUCTR2018-004655-20-GRActive, not recruitingPhase 1
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
HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS0 sites20 target enrollmentStarted: January 31, 2019Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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