Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL (FLASH2)

March 30, 2026 updated by: Soligenix

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Completed
        • Medical Dermatology Specialists
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Aaron Mangold, MD
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • California
      • San Diego, California, United States, 92123
        • Completed
        • Therapeutics Clinical Research
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Dawes Fretzin Dermatology Group
        • Principal Investigator:
          • Kenneth Dawes, MD
        • Contact:
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amy Musiek, MD
    • New York
      • Fairport, New York, United States, 14450
        • Recruiting
        • Rochester Skin Lymphoma Medical Group
        • Contact:
        • Principal Investigator:
          • Brian Poligone, MD, PhD
        • Contact:
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Medical Center
    • North Carolina
      • Wilmington, North Carolina, United States, 28411
        • Completed
        • Accellacare (PMG)
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Ellen Kim, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • Oleg Akilov, MD, PhD
        • Contact:
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Completed
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research
        • Principal Investigator:
          • Edward Lain, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jennifer DeSimone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
  • Patients with a minimum of three (3) evaluable, discrete lesions.
  • Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
  • Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.

Exclusion Criteria:

  • History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions, or radiation therapy within 30 days of enrolling.
  • History of allergy or hypersensitivity to any of the components of HyBryte.
  • A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia's formula).
  • All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
  • Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
  • Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.
  • Patients who have received electron beam irradiation within 3 months of enrollment.
  • Patients with a history of significant systemic immunosuppression.
  • Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
  • Patients whose condition is spontaneously improving.
  • Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
  • Patients with extensive skin disease (>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
  • Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
  • Prior participation in the current study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HyBryte (0.25% Hypericin)
HyBryte gel is applied twice weekly for 18 weeks.
Drug: Hypericin
HyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Other Names:
  • HyBryte
  • SGX301
Placebo Comparator: Placebo
Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.
Drug: Placebo
Placebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
Time Frame: 18 weeks

A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm^2) to 18 (the lesion is larger than 300 cm^2). A lower score means a better outcome.
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patch Lesion Response Rates
Time Frame: 18 weeks

The proportion of patch lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.
18 weeks
Plaque Lesion Response Rates
Time Frame: 18 weeks

The proportion of plaque lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions.

The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soligenix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPN-CTCL-03-EUR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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