Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoligenix
About this trial
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.
Patients with a minimum of three (3) evaluable, discrete lesions.
Patients willing to follow the clinical protocol and voluntarily give their written informed consent.
Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.
Disqualifiers
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.
History of allergy or hypersensitivity to any of the components of HyBryte.
A Screening ECG with a QT interval >470 ms (corrected for heart rate using the Fridericia's formula).
All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.
Trial design
Design model
Parallel
Treatments tested in this trial
Hypericin
DrugHyBryte gel (0.25% hypericin) is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Placebo
DrugPlacebo gel is applied twice weekly for 18 weeks. Treated lesions are covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: HyBryte (0.25% Hypericin)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
A treatment response is defined as a ≥50% improvement in the cumulative mCAILS score of the index lesions at Week 18 when compared to the mCAILS score at baseline. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) 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.
Time frame
18 weeksSecondary outcomes
1
Patch Lesion Response Rates
The proportion of patch lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.
Time frame
18 weeks2
Plaque Lesion Response Rates
The proportion of plaque lesions achieving a treatment response at Week 18. A treatment response is defined as a ≥50% improvement in mCAILS score when compared to the mCAILS score at baseline for individual lesions. The Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.
Time frame
18 weeks Source ClinicalTrials.gov