RECRUITING

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

Conditions

CTCL/ Mycosis Fungoides CTCL Mycosis Fungoides Cutaneous T Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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)

Quick Facts

Study Start:2024-12

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06470451

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Christopher Pullion, DO

CONTACT

609-538-8200

cpullion@soligenix.com

Study Locations (Sites)

Medical Dermatology Specialists

Phoenix, Arizona, 85006

United States

Mayo Clinic

Scottsdale, Arizona, 85259

United States

Therapeutics Clinical Research

San Diego, California, 92123

United States

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256

United States

Washington University

Saint Louis, Missouri, 63110

United States

Rochester Skin Lymphoma Medical Group

Fairport, New York, 14450

United States

Columbia University Medical Center

New York, New York, 10032

United States

Accellacare (PMG)

Wilmington, North Carolina, 28411

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

MD Anderson

Houston, Texas, 77030

United States

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

United States

INOVA Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-12

Study Completion Date2026-10

Study Record Updates

Study Start Date2024-12

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

CTCL/ Mycosis Fungoides
CTCL
Mycosis Fungoides
Cutaneous T Cell Lymphoma