Trial Profile

A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 08 Dec 2025

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At a glance

19 Nov 2025 According to Soligenix media release, planned interim analysis will occur in the second quarter of 2026.
19 Nov 2025 According to Soligenix media release, company announced that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 FLASH2 trial.
23 Sep 2025 According to Soligenix media release, due to the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study is initiated. Discussions with the FDA continue on modifications to the development path to address their feedback.

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