FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Soligenix

Status and phase: Completed; Phase 3

Conditions: Cutaneous T-Cell Lymphoma

Treatments: Drug: Placebo; Drug: SGX301 (synthetic hypericin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448381

HPN-CTCL-01

Details and patient eligibility

About

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
• Subjects must have a minimum of three (3) evaluable, discrete lesions.
• Subjects must be willing to refrain from sunbathing for the duration of the study.

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.
• Pregnancy or mothers who are breast feeding.
• Males and females not willing to use effective contraception.
• Unhealed sunburn.
• Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
• Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
• Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
• Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 2 patient groups, including a placebo group

SGX301

Active Comparator group

Description:

Three treatment cycles, each six (6) weeks followed by a two (2) week rest period. Treatment uses 0.25% SGX301 in USP Hydrophilic Ointment (or placebo) applied twice per week followed by fluorescent light therapy. Cycle 1: Patients randomized 2:1 to active/placebo will have three (3) index lesions treated and evaluated. Cycle 2: All patients will have three (3) index lesions treated and evaluated with active SGX301 ointment. Cycle 3: All patients will be given the opportunity to enter an open-label cycle of active SGX301 ointment treatment for all lesions (index and non-index).

Treatment:

Drug: SGX301 (synthetic hypericin)

Placebo

Placebo Comparator group

Description:

Placebo ointment is indistinguishable from ointment containing active SGX301 and is only used in Cycle 1. Treatment paradigm (ointment application and fluorescent light therapy) is identical.

Treatment:

Drug: Placebo