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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Soligenix
Sponsor
Soligenix
Information Provided by (Responsible Party)
Soligenix
Clinicaltrials.gov Identifier
NCT06470451
Other Study ID Numbers:
HPN-CTCL-03-EUR
First Submitted
June 16, 2024
First Posted
June 23, 2024
Last Update Posted
April 2, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
CTCL/ Mycosis FungoidesCTCLMycosis FungoidesCutaneous T Cell Lymphoma
Drug: HypericinDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment80 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateJanuary 6, 2025
Actual Primary Completion Date1mo 3w from now
Actual Study Completion Date4mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures
  1. Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
    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.
Secondary Outcome Measures
  1. Patch Lesion Response Rates
    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.
  2. Plaque Lesion Response Rates
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSoligenix
Locations
Medical Dermatology Specialists | Phoenix Arizona, United States, 85006Mayo Clinic | Scottsdale Arizona, United States, 85259Therapeutics Clinical Research | San Diego California, United States, 92123University of South Florida | Tampa Florida, United States, 33612Northwestern University | Chicago Illinois, United States, 60611Dawes Fretzin Dermatology Group | Indianapolis Indiana, United States, 46256Washington University | St Louis Missouri, United States, 63110Rochester Skin Lymphoma Medical Group | Fairport New York, United States, 14450Columbia University Medical Center | New York New York, United States, 10032Accellacare (PMG) | Wilmington North Carolina, United States, 28411Penn State Health Hershey Medical Center | Hershey Pennsylvania, United States, 17033Hospital of the University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104University of Pittsburgh Medical Center | Pittsburgh Pennsylvania, United States, 15213Vanderbilt University | Nashville Tennessee, United States, 37212MD Anderson | Houston Texas, United States, 77030Austin Institute for Clinical Research | Pflugerville Texas, United States, 78660Inova Schar Cancer Institute | Fairfax Virginia, United States, 22031