RecruitingRecruiting
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
NCT06470451 · Soligenix
In plain English
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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)
About this study
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.
Eligibility criteria
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 design
Enrollment target: 80 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-01-07
Estimated completion: 2026-10
Last updated: 2026-04-03
Interventions
Drug: HypericinDrug: Placebo
Primary outcomes
- • Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score (18 weeks)
Sponsor
Soligenix · industry
Contacts & investigators
ContactJennifer Bonfrisco · contact · jbonfrisco@soligenix.com · 609-538-8200
All locations (17)
Medical Dermatology SpecialistsCompleted
Phoenix, Arizona, United States
Mayo ClinicRecruiting
Scottsdale, Arizona, United States
Therapeutics Clinical ResearchCompleted
San Diego, California, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Dawes Fretzin Dermatology GroupRecruiting
Indianapolis, Indiana, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Rochester Skin Lymphoma Medical GroupRecruiting
Fairport, New York, United States
Columbia University Medical CenterCompleted
New York, New York, United States
Accellacare (PMG)Completed
Wilmington, North Carolina, United States
Penn State Health Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Vanderbilt UniversityCompleted
Nashville, Tennessee, United States
MD AndersonRecruiting
Houston, Texas, United States
Austin Institute for Clinical ResearchRecruiting
Pflugerville, Texas, United States
Inova Schar Cancer InstituteRecruiting
Fairfax, Virginia, United States