The Benefit of Bermekimab in Patients With Systemic Sclerosis

NCT04045743 | Completed Phase 2

• 1 other identifier: LIGHT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

• Score of inhibition of SSc progression

  A positive score will comprise at least four of the following 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 * Any increase of BMI ( kg/m2 ) * 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 NCMT

  2 years

Secondary Outcomes (1)

• Secondary endpoints

  2 years

Other Outcomes (6)

• Endothelin-1

  2 years

• VEGF

  2 years

• TGFβ

  2 years

Study Arms (2)

Bermekimab (MABp1)

EXPERIMENTAL

Drug: MABp1 (Bermekimab) OR Placebo; Drug: MABp1 (Bermekimab)

Placebo

EXPERIMENTAL

Drug: MABp1 (Bermekimab) OR Placebo; Drug: MABp1 (Bermekimab)

Interventions

MABp1 (Bermekimab) OR Placebo DRUG

Period A: patients randomized 1:1 to weekly subcutaneous treatment with 400mg Bermekimab or matched Placebo for 12 weeks

Bermekimab (MABp1); Placebo

MABp1 (Bermekimab) DRUG

Period B: all patients treated weekly with subcutaneous 400mg Bermekimab for 12 weeks

Bermekimab (MABp1); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (2)

Department of Pathophysiology, LAIKO Athens General Hospital

Athens, Attica, 11527, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients assigned to either subcutaneous Bermekimab or placebo for 12 weeks ( 1:1 randomization, blind period ), then all patients are assigned to subcutaneous Bermekimab for 12 weeks ( open label period )

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: August 6, 2019
• Study Start: July 19, 2019
• Primary Completion: January 7, 2021
• Study Completion: July 19, 2021
• Last Updated: September 29, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)