Phase 3
N=169
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Cutaneous T-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02448381 ↗Enrolled (actual)
169
Serious AEs
1.5%
Results posted
Apr 2022
Primary outcome: Primary: 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 — 19; 2; 97; 48 Participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SGX301 (synthetic hypericin) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Soligenix
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
19; 2; 97; 48 | 0.04 sig |
| SECONDARY 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) |
44; 2; 66; 48 | <0.0001 sig |
| SECONDARY 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 |
38; 40 | 0.046 sig |
| SECONDARY Patch Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) |
65; 14 | =0.0009 sig |
| SECONDARY Plaque Lesion Response Rates With Extended Treatment (Cycle 1 & 2 SGX301 vs Cycle 1 Placebo) |
64; 7 | <0.0001 sig |
Summary
To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02448381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.