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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02682511 | Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension | PHASE2 | ACTIVE NOT_RECRUITING | 34 | — | — | Jan 1, 2017 | Aug 1, 2026 | Apr 15, 2026 | 13 | United States, India |
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
| Arm | Type | Description |
|---|---|---|
| Patients with dcSSc | EXPERIMENTAL | Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
| Patients with SSc-PAH | EXPERIMENTAL | Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
| Name | Type | Description |
|---|---|---|
| Oral Ifetroban | DRUG | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
| Oral Placebo | DRUG | Subjects will be treated with oral ifetroban or placebo daily for 365 days |
Inclusion Criteria: Diffuse Cutaneous Criterion: 1\. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first no...