Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
← catalyst calendarSponsored by Soligenix (industry) · SNGX — their whole pipeline →.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
70actual
Sites
17
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-07 | actual | When the study began enrolling |
| Primary completion | 2026-05-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-22 | actual | The whole study's end, after follow-up |
| First posted | 2024-06-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- CTCL/ Mycosis Fungoides
- CTCL
- Mycosis Fungoides
- Cutaneous T Cell Lymphoma
Interventions
- Drug: Hypericin — also filed as HyBryte, SGX301
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFNumber of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
measured 18 weeks
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