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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07016750 | A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa | PHASE3 | RECRUITING | 16 | — | — | Jun 20, 2025 | Dec 1, 2026 | Mar 12, 2026 | 5 | United States |
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Average number of days per month with corneal abrasion symptoms.
| Arm | Type | Description |
|---|---|---|
| KB803 | EXPERIMENTAL | KB803 |
| Placebo | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| KB803 | BIOLOGICAL | Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus (HSV-1) expressing the human collagen VII protein |
| Placebo | DRUG | Vehicle |
Inclusion Criteria: 1. The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and instructions. 2. Age 6 months or older at time of informed consent/assent. 3. Confirmed diagnosis of DEB with a mutation in the C...