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

Phase 3

Completed

• Conditions: Cutaneous T-Cell Lymphoma
• Interventions: Drug: SGX301 (synthetic hypericin); Drug: Placebo

• Registration Number: NCT02448381
• Lead Sponsor: Soligenix

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Study Start: 2015-12
• Primary Completion: 2020-06
• Study Completion: 2020-11
• Results First Submitted: 2022-02-14
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Results First Posted: 2022-04-15
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGX301	SGX301 (synthetic hypericin)	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).
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score When Compared to Patients Receiving Placebo	8 weeks	The percentage of patients achieving a treatment response in each of the 2 treatment groups. A treatment response was defined as a ≥50% improvement in CAILS score at Week 8 when compared to the CAILS score at baseline.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score measures: Erythema (or redness) on a scale of 0 (no redness) to 8 (very red), Scaling on a scale of 0 (no scaling) to 8 (all of the lesion is covered by a very rough surface), Plaque Elevation on a scale of 0 (no evidence of plaque above normal skin level) to 3 (plaque shows marked elevation above normal skin level) and Surface Area on a scale of 0 (no lesion/surface area is 0 cm\^2) to 18 (the lesion is larger than 300 cm\^2). A lower score means a better outcome.; The overall CAILS score was calculated by adding the total score as described above for each of the 3 lesions. The overall CAILS score has a range of 0 to 111. A lower score means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Number of Responders and Non-Responders With a Treatment Response of 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score in Patients Who Received 3 Cycles of SGX301	24 weeks	The percentage of patients achieving a treatment response at Week 24 compared at Week 16 in SGX301 treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.
Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Measured by the Composite Assessment of Index Lesion Disease Severity (CAILS) Score (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo)	16 weeks	The percentage of patients achieving a treatment response at Week 16 that received SGX301 for both Cycle 1 and 2 compared to the response rate in patients that received Placebo in Cycle 1.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.
Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	16 weeks	The proportion of patch lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.
Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo)	16 weeks	The proportion of plaque lesions achieving a treatment response at Week 16 in the SGX301 treatment group compared to Week 8 in the Placebo treatment group. A treatment response was defined as a ≥50% improvement in CAILS score when compared to the CAILS score at baseline for individual lesions.; The Composite Assessment of Index Lesion Disease Severity (CAILS) score was measured as previously described.

Trial Locations

Locations (33)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Olympian Clinical Research; 🇺🇸 Clearwater, Florida, United States

Leon Medical Research; 🇺🇸 Miami, Florida, United States

Medical Professional Clinical Research; 🇺🇸 Miami, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

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