Clinical trial NCT06470451: Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: CTCL/ Mycosis Fungoides
CTCL
Mycosis Fungoides
Cutaneous T Cell Lymphoma
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
timeFrame: 18 weeks
Secondary outcomes:
measure: Patch Lesion Response Rates
timeFrame: 18 weeks
measure: Plaque Lesion Response Rates
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Fairport
country: United States
facility: Rochester Skin Lymphoma Medical Group
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Wilmington
country: United States
facility: Accellacare (PMG)
state: North Carolina
city: Hershey
country: United States
facility: Penn State Health Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
References: