Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Summary

To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Timeline

Start

2025-01-07

Primary completion

2026-05-22

Completion

2026-05-22

Outcome

Missed primary endpoint

Stopped: “The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility”

release “the second HyBryte™ (SGX301) Phase 3 clinical trial did not demonstrate sufficient efficacy at the interim analysis to support continuation of the study” soligenix.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hypericin	Other / unclassified	0.25 %	Topical

Indications