Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
Status:
Active, not recruiting
Trial end date:
2021-01-30
Target enrollment:
Participant gender:
Summary
Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the
pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands. This
Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of
AVID200 in SSc patients in order delineate doses to be further evaluated in Phase 2.
Approximately 9 to 24 male and female patients with documented SSc (i.e., score ≥ 9 according
to the American College of Rheumatology/European League Against Rheumatism classification
criteria), and classified as having the diffuse cutaneous SSs (dcSSc) subset (i.e., according
to the LeRoy and Medsger Classification), will be entered into this Phase 1a, multicentre,
open-label, dose-escalation, cohort study of AVID200.