Status:
COMPLETED
The Benefit of Bermekimab in Patients With Systemic Sclerosis
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
Scleroderma, Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a proof-of concept RCT trying to generate evidence that inhibition of IL-1α through the administration of bermekimab may inhibit progression of SSc.
Detailed Description
Systemic sclerosis (SSc also known as scleroderma) is a devastating chronic immune-mediated inflammatory syndrome that is characterized by progressive organ dysfunction. The most common affected syste...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Age more than or equal to 18 years
- Both genders
- In the case of women of childbearing age, an adequate method of contraception should be used during the study. Contraception should be maintained at least until discontinuation of treatment. Prior to admission to the study, a pregnancy test will be performed to exclude pregnancy.
- 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
- EXCLUSION CRITERIA
- 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-γ 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
Exclusion
Key Trial Info
Start Date :
July 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04045743
Start Date
July 19 2019
End Date
July 19 2021
Last Update
September 29 2022
Active Locations (2)
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1
Department of Pathophysiology, LAIKO Athens General Hospital
Athens, Attica, Greece, 11527
2
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Attica, Greece, 12462