Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis (NCT03831438) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
United States9 participantsStarted 2019-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with the ability to understand and give written informed consent
* Male or female patients, ≥ 18 years
* Patients classified as having systemic sclerosis (SSc) with a total ≥ 9 according to the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria for the classification of SSc
* Patients classified as having diffuse cutaneous SSc (dcSSc) subset
* Patients with \< 5 years since the onset of first SSc manifestations, other than Raynaud's phenomenon, at the time of enrollment
* Patients with a MRSS ≥ 15, and with a score that has not decreased by \> 5 points in the past 2 months (8 weeks)
* Patients with a skin score ≥ 2 on at least one forearm
* Persons of childbearing potential agreeing to use a highly effective, non-hormonal method of contraception during the study
Exclusion Criteria:
* Women who are pregnant or intending to become pregnant before study, during study or within 3 months after the last dose of study drug; women who are breastfeeding
* Patients with any of the following hematologic abnormalities at baseline:
* Hemoglobin \< 10.0 g/dL\*
* Absolute neutrophil count (ANC) \< 1,500 per mm3
* Platelet count \< 100,000 per mm3
* Iron, iron binding, and transferrin studies to be performed at screening; patients with documented iron deficiency to receive repletion prior to receiving study drug
* Patients with any of the following serum chemistry abnormalities at baseline:
* Total bilirubin …
What they're measuring
1
Primary Outcome: Incidence of treatment related adverse events