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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome: Incidence of treatment related adverse events