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: 02 Aug 2025

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At a glance

08 Jul 2025 According to Soligenix media release, an enrollment is currently on track, with an enrollment update coming later this year.
14 Jan 2025 According to Soligenix media release, Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is expected to be initiated before the end of 2024.
20 Dec 2024 Planned initiation date (date of first subject enrollement) changed from 1 Oct 2024 to 1 Dec 2024.

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