A Confirmatory Phase 3 Trial of HyBryte in Early-Stage Cutaneous T-Cell Lymphoma (CTCL)

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1011027

• Contact name

  Andrea Haulenbeek

• Contact email

  ahaulen@soligenix.com

• Sponsor organisation

  Soligenix Inc.

• Clinicaltrials.gov Identifier

  NCT06470451

• Research summary

  The aim of this study is to evaluate the safety and efficacy of 18 weeks of HyBryte (hypericin sodium) gel treatment in combination with visible light therapy in patients with cutaneous T-cell lymphoma (CTCL), when compared to placebo.
  Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma that affects the skin. It is estimated to affect approximately 50,000 to 100,000 individuals in the US & Europe. The causes of CTCL are not fully understood.
  In the early stages, CTCL can look like other more common skin conditions, such as eczema or psoriasis. This may mean it takes some time to diagnose.
  It is usually diagnosed by a biopsy, where a doctor will take a sample of tissue from an affected area of skin.
  Doctors usually use treatments to treat the skin directly when CTCL is at an early stage. These include creams or gels applied directly to the skin, light therapy, and radiotherapy. Advanced CTCL may also be treated with medicines given as tablets or as an injection.
  Approximately 80 CTCL patients will be enrolled into this study at approximately 20 centres in the UK, Europe and US. They will have an equal chance of receiving HyBryte or placebo.
  The participants, once they have agreed to participate, will be asked to apply treatment to their lesions twice weekly for 18 weeks, cover them with opaque material, and attend the clinic the next day for light treatment administered by the clinic staff. The aim is to compare the amount their CTCL patch/plaque lesions shrink compared to patients receiving placebo and the same visible light treatments. Treatment response is defined as an improvement of ≥50% in a score assessing the severity of lesions when compared to the patient’s score at baseline evaluation.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0126

• Date of REC Opinion

  1 Jul 2025

• REC opinion

  Further Information Favourable Opinion