Phase 2
N=9
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Bottom Line
View on ClinicalTrials.gov: NCT05380635 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Electrocardiograms (ECG) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hypericin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Soligenix
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electrocardiograms (ECG) |
— | — |
| PRIMARY Systemic Blood Levels |
0.00013 | — |
| SECONDARY 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. |
2; 7 | — |
| SECONDARY Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. |
7; 20 | — |
| SECONDARY Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score. |
4; 23 | — |
Summary
To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
- CTCL lesions covering ≥ 10% of their body surface area
Exclusion Criteria
- History of allergy or hypersensitivity to any of the components of HyBryte
- Pregnancy or mothers who are breast-feeding
- Males and females not willing to use effective contraception
- Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
- Subjects whose condition is spontaneously improving
- Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
- Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
- Subjects who have received electron beam irradiation within 3 months of enrollment
- Subjects with a history of significant systemic immunosuppression
- Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
- Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
Data sourced from ClinicalTrials.gov (NCT05380635). 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.