MedTrace Logo

The Benefit of Bermekimab in Patients With Systemic Sclerosis

NCT04045743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-29

No results posted yet for this study

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

Interventions

DRUG

MABp1 (Bermekimab) OR Placebo

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

DRUG

MABp1 (Bermekimab)

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

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2021-01-07
Completion
2021-07-19

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045743 on ClinicalTrials.gov