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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05892614 | Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD) | PHASE2 | RECRUITING | 25 | — | — | Oct 26, 2023 | Apr 1, 2026 | May 7, 2025 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| efzofitimod 450 mg | EXPERIMENTAL | Administered IV infusion |
| efzofitimod 270 mg | EXPERIMENTAL | Administered IV infusion |
| Placebo | PLACEBO_COMPARATOR | Administered IV infusion |
| Name | Type | Description |
|---|---|---|
| efzofitimod 450 mg | DRUG | IV infusion over approximately 60 minutes every 4 weeks |
| efzofitimod 270 mg | DRUG | IV infusion over approximately 60 minutes every 4 weeks |
| Placebo | DRUG | IV infusion over approximately 60 minutes every 4 weeks |
Inclusion Criteria: 1. Diagnosis of SSc based on ACR/ EULAR criteria (2013) 2. Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1 3. HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated ...