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

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

NCT ID: NCT06470451

Condition: CTCL/ Mycosis Fungoides
CTCL
Mycosis Fungoides
Cutaneous T Cell Lymphoma

Conditions: Official terms:
Mycoses
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Hypericin

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Hypericin
Description: 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.
Arm group label: HyBryte (0.25% Hypericin)

Other name: HyBryte

Other name: SGX301

Intervention type: Drug
Intervention name: Placebo
Description: 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.
Arm group label: Placebo

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: October 2024

Completion date: October 2026

Lead sponsor:
Agency: Soligenix
Agency class: Industry

Source: Soligenix

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06470451