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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06470451 | Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL | PHASE3 | RECRUITING | 80 | — | — | Jan 7, 2025 | Oct 1, 2026 | Apr 3, 2026 | 17 | United States |
A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.
| Arm | Type | Description |
|---|---|---|
| HyBryte (0.25% Hypericin) | EXPERIMENTAL | HyBryte gel is applied twice weekly for 18 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks. |
| Name | Type | Description |
|---|---|---|
| Hypericin | DRUG | HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. |
| Placebo | DRUG | Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. |
Inclusion Criteria: * Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA. * Patients with a minimum of three (3) evaluable, discrete lesions. * Patients willing to follow the clinical protocol and voluntarily give their written informed con...