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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03763318 | A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD | PHASE1 | COMPLETED | 30 | — | — | Jul 15, 2019 | Nov 21, 2022 | Apr 18, 2025 | 16 | United States |
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.
| Arm | Type | Description |
|---|---|---|
| EQ001 Dose Escalation (Part A) | EXPERIMENTAL | Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses. |
| EQ001 (Part B) | EXPERIMENTAL | EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses. |
| EQ001 Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses. |
| Name | Type | Description |
|---|---|---|
| EQ001 | BIOLOGICAL | Itolizumab \[Bmab 600\]) |
| EQ001 Placebo | BIOLOGICAL | EQ001 Placebo |
Inclusion Criteria: 1. Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B. 2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens. 3. Have a clinical diagnosis of ...