Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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)

Next Previous
X
Search
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: 19 Mar 2025

Price :

$35 *

Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Hypericin sodium (Primary)
  • Indications Cutaneous T-cell lymphoma
  • Focus Therapeutic Use
  • Acronyms FLASH2
  • Sponsors Soligenix

    • Most Recent Events

    • 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.
    • 16 Dec 2024 According to Soligenix media release, FLASH2 is expected to enroll patients in the United States (U.S.) and Europe, with a formal interim analysis anticipated early in 2026. Company look forward to providing periodic updates on the trial's progress in 2025.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top