The Benefit of Bermekimab in Patients With Systemic Sclerosis

• Status: Active, not recruiting
• Trial end date: 2021-07-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Criteria

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