Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03831438 | Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis | PHASE1 | COMPLETED | 9 | — | — | Jan 1, 2019 | Jun 20, 2020 | Nov 19, 2024 | 4 | United States |
Incidence of treatment related adverse events
| Arm | Type | Description |
|---|---|---|
| Dose escalation | OTHER | 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). |
| Name | Type | Description |
|---|---|---|
| AVID200 | DRUG | Intravenous infusion of AVID200 Q2 weeks for 3 doses |
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/E...