Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-01 @ 10:02 PM
Study NCT ID:
NCT06470451
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2024-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004965', 'term': 'hypericin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with a Treatment Response in the Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score', 'timeFrame': '18 weeks', 'description': '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.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Patch Lesion Response Rates', 'timeFrame': '18 weeks', 'description': '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.\n\nThe Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.'}, {'measure': 'Plaque Lesion Response Rates', 'timeFrame': '18 weeks', 'description': '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.\n\nThe Modified Composite Assessment of Index Lesion Disease Severity (mCAILS) score is measured as previously described.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CTCL/ Mycosis Fungoides', 'CTCL', 'Mycosis Fungoides', 'Cutaneous T Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL), Stage IA, Stage IB, or Stage IIA.\n* Patients with a minimum of three (3) evaluable, discrete lesions.\n* Patients willing to follow the clinical protocol and voluntarily give their written informed consent.\n* Female patients not pregnant or nursing and willing to undergo a pregnancy test within 30 days prior to treatment initiation.\n\nExclusion Criteria:\n\n* 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.\n* History of allergy or hypersensitivity to any of the components of HyBryte.\n* A Screening ECG with a QT interval \\>470 ms (corrected for heart rate using the Fridericia's formula).\n* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to use effective contraception.\n* Patients receiving topical steroids or other topical treatments (eg, nitrogen mustard) on treated lesions for CTCL within 2 weeks of enrollment.\n* 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.\n* Patients who have received electron beam irradiation within 3 months of enrollment.\n* Patients with a history of significant systemic immunosuppression.\n* Patients taking other investigational drugs or drugs of abuse within 30 days of entry into this study.\n* Patients whose condition is spontaneously improving.\n* Patients with tumor stage or erythrodermic CTCL (stages IIB-IV).\n* Patients with extensive skin disease (\\>30% body surface area) who would be, in the judgement of the Principal Investigator, candidates for systemic treatment.\n* Patient has any condition that, in the judgment of the PI, is likely to interfere with participation in the study.\n* Prior participation in the current study."}, 'identificationModule': {'nctId': 'NCT06470451', 'acronym': 'FLASH2', 'briefTitle': 'Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soligenix'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'HPN-CTCL-03-EUR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HyBryte (0.25% Hypericin)', 'description': 'HyBryte gel is applied twice weekly for 18 weeks.', 'interventionNames': ['Drug: Hypericin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo gel is indistinguishable from HyBryte gel, and is applied twice weekly for 18 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hypericin', 'type': 'DRUG', 'otherNames': ['HyBryte', 'SGX301'], 'description': '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.', 'armGroupLabels': ['HyBryte (0.25% Hypericin)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla Heraty', 'role': 'CONTACT', 'email': 'kheraty@usdermpartners.com', 'phone': '602-354-5770', 'phoneExt': '4276'}, {'name': 'Nathalie Zeitouni, MD', 'role': 'CONTACT', 'email': 'nathaliezeitouni@email.arizona.edu'}, {'name': 'Nathalie Zeitouni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Dermatology Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'phone': '855-776-0015'}, {'name': 'Aaron Mangold, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hector Bailon', 'role': 'CONTACT', 'email': 'hbailon@therapeuticsresearch.com', 'phone': '858-571-6800', 'phoneExt': '141'}, {'name': 'Neal Bhatia, MD', 'role': 'CONTACT', 'email': 'nbhatia@therapeuticsresearch.com'}, {'name': 'Neal Bhatia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deptarment of Dermatology Research', 'role': 'CONTACT', 'email': 'NUderm-research@northwestern.edu'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lana Johnson', 'role': 'CONTACT', 'email': 'ljohnson2e902@ecommunity.co', 'phone': '317-516-5030', 'phoneExt': '109'}, {'name': 'Kenneth Dawes, MD', 'role': 'CONTACT', 'email': 'kdawes@ecommunity.com', 'phone': '317-516-5030'}, {'name': 'Kenneth Dawes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dawes Fretzin Dermatology Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jian Yang', 'role': 'CONTACT', 'email': 'yang983@wustl.edu', 'phone': '314-273-3737'}, {'name': 'Amy Musiek, MD', 'role': 'CONTACT', 'email': 'amusiek@wustl.edu', 'phone': '314-362-8171'}, {'name': 'Amy Musiek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14450', 'city': 'Fairport', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lily Hauschildt', 'role': 'CONTACT', 'email': 'lhauschildt@roclymphoma.com', 'phone': '585 364-1188'}, {'name': 'Brian Poligone, MD, PhD', 'role': 'CONTACT', 'email': 'bpoligone@roclymphoma.com', 'phone': '585-364-2075'}, {'name': 'Brian Poligone, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rochester Skin Lymphoma Medical Group', 'geoPoint': {'lat': 43.09867, 'lon': -77.44194}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28411', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Accellacare (PMG)', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dermatology Clinical Trials Office', 'role': 'CONTACT', 'email': 'dermatologyclinicaltrial@pennstatehealth.psu.edu', 'phone': '717-531-5136'}, {'name': 'Christopher Bazewicz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penn State Health Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Cesar', 'role': 'CONTACT', 'email': 'laura.cesar@pennmedicine.upenn.edu', 'phone': '445-800-6538'}, {'name': 'Ellen Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Liotta', 'role': 'CONTACT', 'email': 'liottada3@upmc.edu', 'phone': '412-864-3681'}, {'name': 'Oleg Akilov, MD, PhD', 'role': 'CONTACT', 'email': 'akilovoe@upmc.edu', 'phone': '412 864-3717'}, {'name': 'Oleg Akilov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alda Ashu', 'role': 'CONTACT', 'email': 'abmiraso@mdanderson.org', 'phone': '713-792-1280'}, {'name': 'Auris Huen, MD', 'role': 'CONTACT', 'email': 'aohuen@mdanderson.org'}, {'name': 'Auris Huen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tommy Ha', 'role': 'CONTACT', 'email': 'tha@atxresearch.com', 'phone': '512-279-2545'}, {'name': 'Edward Lain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Austin Institute for Clinical Research', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Jeffords', 'role': 'CONTACT', 'email': 'Kelly.Jeffords@inova.org', 'phone': '703-970-6548'}, {'name': 'Jennifer DeSimone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inova Schar Cancer Institute', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Jennifer Bonfrisco', 'role': 'CONTACT', 'email': 'jbonfrisco@soligenix.com', 'phone': '609-538-8200', 'phoneExt': '139'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soligenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}