Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:27 AM
Study NCT ID:
NCT07414550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy for Refractory Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Within Participant (Split-Body Design)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HS Disease Activity', 'timeFrame': 'Baseline (within 7 days prior to first radiotherapy treatment) to 12 weeks after completion of radiotherapy', 'description': 'Change in the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla.'}], 'secondaryOutcomes': [{'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy', 'description': 'Change in quality of life as measured by DLQI. A list of 10 questions graded on a likert scale. The mimimum selection is "Not at all" or "No", the maximum selection is "Very much" or "Yes". Depending on the question phrasing the maximum or minimum scores could correlate to a positive or negative outcome.'}, {'measure': 'Pain and Symptom Burden (Numerical Rating Scale)', 'timeFrame': 'Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy', 'description': 'Patient-reported symptom severity using a numerical rating scale. This is a list of survey questions, with each question having a correlating likert scale. For each question, the lowest score would be 0 and the highest score would be 10. Depending on the question phrasing the maximum or minimum scores could correlate to a positive or negative outcome.'}, {'measure': 'Duration Without HS Flare', 'timeFrame': 'Up to 2 years post-radiotherapy (chart review)', 'description': 'Time to disease flare in the treated axilla, defined as increased lesion counts, ≥2-point HS-PGA increase, or initiation of rescue therapy'}, {'measure': 'Radiation-Related Toxicities', 'timeFrame': 'During radiotherapy and through 12 weeks post-treatment', 'description': 'Incidence and grading of radiation-induced toxicities (per CTCAE criteria) will also be assessed as a safety endpoint.'}, {'measure': 'Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score', 'timeFrame': 'Baseline (within 1 week of first radiotherapy treatment) and 4 weeks after completion of radiotherapy', 'description': 'Change in HS disease activity, measured by HS-Physician Global Assessment (HS-PGA) score. Minimum score is zero and maximum score is 5. A higher score would indicate a worse outcome.'}, {'measure': 'Response Rates', 'timeFrame': '12 weeks post-radiotherapy', 'description': 'Partial response: ≥1-point decrease in HS-PGA Complete response: ≥2-point decrease in HS-PGA'}, {'measure': 'Optional: Histopathological Characterization in Treated Skin', 'timeFrame': 'Baseline and 12 weeks post-radiotherapy biopsies. This is only in the subset of participants that agreed to participate in this arm of the trial.', 'description': 'This outcome will characterize the histopathologic features seen from punch biopsies. Participation in this is optional to participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis suppurativa', 'HS', 'Radiotherapy', 'Radiation', 'Treatment resistant'], 'conditions': ['Hidradenitis Suppurativa (HS)']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if high-dose radiotherapy can provide sustained disease relief in moderate to severe, treatment resistant Hidradenitis suppurativa patients; could include any of the following: any sex/gender, and those greater then 18 years old. The main question\\[s\\] it aims to answer are:\n\nOutcome measure 1: Will radiotherapy change the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla? Outcome measure 2: Will radiotherapy positively change a patient's quality of life, pain levels and symptom burden?\n\nParticipants will receive radiotherapy to one axilla affected by hidradenitis suppurativa. The contralateral axilla will not receive radiotherapy and will continue receiving the standard treatment regimen.\n\nParticipants will...\n\n* Attend a baseline dermatology skin evaluation, complete multiple surveys and an optional participation in a biopsy\n* Attend multiple radiation sessions over 5 weeks\n* Attend 2 follow up visits with dermatology for skin evaluation, complete follow up surveys, and an optional biopsy.", 'detailedDescription': 'This is a prospective, non-randomized, split-body interventional study enrolling adults with moderate to severe hidradenitis suppurativa involving bilateral axillary disease of comparable severity. Each participant will receive radiotherapy to one axilla, while the contralateral axilla will serve as an untreated within-subject control.\n\nRadiotherapy will be delivered to a total dose of 45 Gy in 15 fractions (3 Gy per fraction), administered three times per week over approximately five weeks.\n\nPatients will continue stable background HS therapies during the study period. Dermatologic assessments, lesion counts, physician global assessment scores, and patient-reported outcomes will be collected at baseline, during treatment, and at 4 and 12 weeks following completion of radiotherapy. Long-term safety and disease outcomes will be assessed by chart review for up to two years post-treatment. An optional punch biopsy sub-study will evaluate histologic changes associated with treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between the age of 18 or older with moderate or severe HS (Hurley Stage II or III) with bilateral axillary disease of approximately equivalent disease severity will be included.\n* Patients on topical and/or systemic HS medications for at least 1 month will continue maintenance treatment throughout the study period as per standard of care.\n* Patients willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy - Women of childbearing potential must use trial approved birth control and obtain a negative pregnancy test 7 days prior to radiotherapy CT simulation.\n* Severe autoimmune conditions including lupus, scleroderma and mixed connective tissue disease\n* Poorly controlled diabetes per physician discretion, HIV, Hepatitis B/C.\n* Prior therapeutic radiotherapy.\n* Active malignancy.\n* Contraindication to radiotherapy as determined by treating radiation oncologist.\n* Patients who began new systemic treatment for their HS \\<1 month prior to enrollment in trial\n* History of photosensitivity disorders or prior radiation sensitization syndromes\n* Any contraindication to radiotherapy as determined by the treating radiation oncologist.'}, 'identificationModule': {'nctId': 'NCT07414550', 'acronym': 'RADIANTSUPPoRT', 'briefTitle': 'Radiotherapy for Refractory Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Radiotherapy for Treatment of Recalcitrant Hidradenitis Suppurativa (RADIANT-SUPPoRT)', 'orgStudyIdInfo': {'id': 'TJUH-RADIANT-SUPPoRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation axilla', 'description': 'Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa.', 'interventionNames': ['Radiation: Radiated axilla']}, {'type': 'NO_INTERVENTION', 'label': 'Non-radiated Axilla', 'description': 'The contralateral axilla will not receive radiotherapy and will continue on the current standard of care.'}], 'interventions': [{'name': 'Radiated axilla', 'type': 'RADIATION', 'description': 'Intervention: Radiation\n\nTotal dose: 45 Gy Fractionation: 3 Gy per fraction Schedule: Three fractions per week for approximately five weeks', 'armGroupLabels': ['Radiation axilla']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gregory Alexander, MD', 'role': 'CONTACT', 'email': 'gregory.alexander@jefferson.edu', 'phone': '856-922-4800'}, {'name': 'Sherry Yang, MD', 'role': 'CONTACT', 'email': 'Sherry.Yang@jefferson.edu', 'phone': '215-955-6680'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gregory Alexander', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}