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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: CTCL/ Mycosis Fungoides, CTCL, Mycosis Fungoides, Cutaneous T Cell Lymphoma

In brief

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

Key facts

Study ID

NCT06470451

Run by

Soligenix

People needed

70

Starts

2025-01-07

Expected to finish

2026-05-22

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Dermatology Specialists — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Therapeutics Clinical Research — San Diego, California, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States
• Washington University — St Louis, Missouri, United States
• Rochester Skin Lymphoma Medical Group — Fairport, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Accellacare (PMG) — Wilmington, North Carolina, United States
• Penn State Health Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• Austin Institute for Clinical Research — Pflugerville, Texas, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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