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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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CTCL/ Mycosis Fungoides CTCL Mycosis Fungoides Cutaneous T Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HyBryte (0.25% Hypericin)

HyBryte gel is applied twice weekly for 18 weeks.

Group Type EXPERIMENTAL

Hypericin

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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HyBryte SGX301

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

HyBryte (0.25% Hypericin)

Hypericin

Placebo

Placebo

Interventions

Hypericin

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Soligenix

Responsible Party

Locations

Medical Dermatology Specialists

Mayo Clinic

Therapeutics Clinical Research

University of South Florida

Northwestern University

Dawes Fretzin Dermatology Group

Washington University

Rochester Skin Lymphoma Medical Group

Columbia University Medical Center

Accellacare (PMG)

Penn State Health Hershey Medical Center

Hospital of the University of Pennsylvania

University of Pittsburgh Medical Center

Vanderbilt University

MD Anderson

Austin Institute for Clinical Research

Inova Schar Cancer Institute

Countries

Central Contacts

Jennifer Bonfrisco

Facility Contacts

Kayla Heraty

Nathalie Zeitouni, MD

Clinical Trials Referral Office

Hector Bailon

Neal Bhatia, MD

Deptarment of Dermatology Research

Lana Johnson

Kenneth Dawes, MD

Jian Yang

Amy Musiek, MD

Lily Hauschildt

Brian Poligone, MD, PhD

Dermatology Clinical Trials Office

Laura Cesar

David Liotta

Oleg Akilov, MD, PhD

Alda Ashu

Auris Huen, MD

Tommy Ha

Kelly Jeffords

Other Identifiers

HPN-CTCL-03-EUR