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TGF-β Ligand Inhibitor

Dose escalation for Scleroderma

Phase 1
Waitlist Available
Research Sponsored by Formation Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

Study 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.

Eligible Conditions
  • Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
: Incidence of treatment related adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Sequential escalating doses of AVID200 when administered once every 2 weeks (Q2W) by 1-hour intravenous (IV) infusion to patient cohorts with diffuse cutaneous systemic sclerosis (dcSSc). Each 2-week dosing period equals 1 cycle; patients may receive up to 3 cycles of AVID200 (i.e., dosing on D1, 15, and 29 of overall 6 week treatment period).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AVID200
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Formation BiologicsLead Sponsor
3 Previous Clinical Trials
89 Total Patients Enrolled
Robert Lafyatis, MDStudy ChairUniversity of Pittsburgh Medical Center
3 Previous Clinical Trials
65 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
2019. "Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03831438.
All > Scleroderma Research Foundation
~4 spots leftby May 2025
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