CTCL/ Mycosis FungoidesPhase 3FLASH2NCT06470451
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
A Phase 3 study testing Hypericin in people with CTCL/ Mycosis Fungoides and CTCL, run by Soligenix at 17 sites in United States.
Trial summary
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTCL/ Mycosis Fungoides, CTCL, Mycosis Fungoides
- What is being tested?
- Hypericin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 17 sitesUnited States
- Study dates
- 7 Jan 2025to 22 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
- Patients receiving systemic steroids, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 4 weeks of enrollment.
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- Patients who have received electron beam irradiation within 3 months of enrollment.
- Patients with a history of significant systemic immunosuppression.
- Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
- Patients whose condition is spontaneously improving.
- Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).
- Patients with extensive skin disease (>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.
- Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.
- Prior participation in the current study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Northwestern University
Chicago, Illinois, 60611
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Rochester Skin Lymphoma Medical Group
Fairport, New York, 14450
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson
Houston, Texas, 77030
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256
Vanderbilt University
Nashville, Tennessee, 37212
Columbia University Medical Center
New York, New York, 10032
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Medical Dermatology Specialists
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Therapeutics Clinical Research
San Diego, California, 92123
Mayo Clinic
Scottsdale, Arizona, 85259
Washington University
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33612
Accellacare (PMG)
Wilmington, North Carolina, 28411
About this study
Official title: A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Read the detailed description
The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session.
- Being tested
- Hypericin, Placebo
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypericinDrug
Also called HyBryte, SGX301
HyBryte 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.
PlaceboDrug
Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| HyBryte (0.25% Hypericin) | Experimental | HyBryte gel is applied twice weekly for 18 weeks. Receives: Drug: Hypericin |
| Placebo | Placebo comparator | Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks
Secondary outcomes (2)
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.
Measured: 18 weeks
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start7 Jan 2025
- Primary completion22 May 2026
- Study completion22 May 2026
Why it stopped: The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTCL/ Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470451
- Sponsor's protocol ID
- HPN-CTCL-03-EUR
- Acronym
- FLASH2
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
- ClinicalTrials.gov ID
- NCT06470451
- Acronym / sponsor ID
- FLASH2 / HPN-CTCL-03-EUR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).
Detailed description
The primary objective of this Phase 3 study is to evaluate the ability of an 18-week course of HyBryte and visible light to induce a Treatment Response in patients with patch/plaque phase CTCL compared to patients receiving placebo and visible light.The study will evaluate the efficacy and safety of HyBryte (0.25% hypericin) gel or placebo gel applied twice weekly for 18 weeks. Treated lesions will be covered with opaque material (such as opaque clothing), followed 21 (±3) hours later by the administration of visible light. All of the participant's lesions that are readily available for exposure to the visible light source will be treated and 3 to 5 index lesions in each patient will be prospectively identified and documented for modified Composite Assessment of Index Lesion Severity (mCAILS) evaluation. Participants will be followed every 4 weeks for a total of 12 weeks following their last light session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HyBryte (0.25% Hypericin) | Experimental | Drug: HypericinHyBryte gel is applied twice weekly for 18 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypericinAlso: HyBryte, SGX301HyBryte 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. | Drug | HyBryte (0.25% Hypericin) |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score
Time frame: 18 weeks
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.
2 secondary outcomes
Patch Lesion Response Rates
Time frame: 18 weeks
Plaque Lesion Response Rates
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypericin in people with CTCL/ Mycosis Fungoides and CTCL, run by Soligenix at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.