[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647862":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":11,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"SecuraBio","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Duvelisib","EXPERIMENTAL",null,[13],"Drug: Duvelisib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Topical gel",[9],[20],"SBI-0145",[22],{"name":23,"affiliation":24,"role":25},"Reuven Chantre, MD","Secura Bio, Inc.","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Medical Director","CONTACT","1-858-251-1414","TopicalStudy@securabio.com",[33],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":11},"Johns Hopkins University","Baltimore","Maryland","21218","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-76.61219,39.29038,{"lat":44,"lon":43},{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100647862","phase-1-a-study-of-topical-duvelisib-in-participants-with-early-stage-mycosis-fungoides-100647862",false,"NCT07714187","A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides","A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides","Key Inclusion Criteria:\n\n* Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).\n* Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.\n* Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.\n\nKey Exclusion Criteria:\n\n* Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.\n* Have histopathologically confirmed lymph node involvement.\n* Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.\n* Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.\n* Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.\n* Received electron beam irradiation within the 3 months prior to starting study drug.\n\nNote: other protocol-defined criteria apply.","ALL","18 Years",{"count":58,"type":59},30,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.",[65,66],"Mycosis Fungoides","Cutaneous T-cell Lymphoma",[68,9,69],"Early-stage mycosis fungoides","Topical","NOT_YET_RECRUITING","2026-07-15",{"date":73,"type":74},"2026-07-20","ACTUAL",{"date":76,"type":59},"2027-01",{"date":78,"type":59},"2029-01",{"name":5,"class":6},1]