Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:03 PM
Study NCT ID:
NCT04988256
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-30
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclosporine Vs Steroids in DRESS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063926', 'term': 'Drug Hypersensitivity Syndrome'}], 'ancestors': [{'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-07-31', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy', 'timeFrame': 'Day 7', 'description': 'Measured by the following quantitative metrics:\n\n* Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher\n* Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher\n* Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher\n* Resolution of interstitial pneumonitis on chest x-ray'}, {'measure': 'Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy', 'timeFrame': 'Day 30', 'description': 'Measured by the following quantitative metrics:\n\n* Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher\n* Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher\n* Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher\n* Resolution of interstitial pneumonitis on chest x-ray'}, {'measure': 'Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy', 'timeFrame': 'Day 7', 'description': 'Clinical measurement of erythema'}, {'measure': 'Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy', 'timeFrame': 'Day 30', 'description': 'Clinical measurement of erythema'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with resolution of fever', 'timeFrame': 'Day 7', 'description': 'Less than 38 degrees Celsius for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of fever', 'timeFrame': 'Day 30', 'description': 'Less than 38 degrees Celsius for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of facial edema', 'timeFrame': 'Day 7', 'description': 'Clinical resolution of edema for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of facial edema', 'timeFrame': 'Day 30', 'description': 'Clinical resolution of edema for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of pruritus', 'timeFrame': 'Day 7', 'description': 'Resolution for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of pruritus', 'timeFrame': 'Day 30', 'description': 'Resolution for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of lymphadenopathy', 'timeFrame': 'Day 7', 'description': 'Clinical resolution of lymphadenopathy for at least 24 hours'}, {'measure': 'Percentage of patients with resolution of lymphadenopathy', 'timeFrame': 'Day 30', 'description': 'Clinical resolution of lymphadenopathy for at least 24 hours'}, {'measure': 'Absolute eosinophil proportion compared to peak value', 'timeFrame': 'Day 7', 'description': 'Proportion of absolute eosinophils'}, {'measure': 'Absolute eosinophil proportion compared to peak value', 'timeFrame': 'Day 30', 'description': 'Proportion of absolute eosinophils'}, {'measure': 'Patients with autoimmune disease development', 'timeFrame': 'Day 30', 'description': 'Measured by titers of autoimmune markers (Antinuclear Antibody (ANA), Thyroid Stimulating Hormone (TSH)) compared to baseline'}, {'measure': 'Patients with autoimmune disease development', 'timeFrame': 'Day 90', 'description': 'Measured by titers of autoimmune markers (Antinuclear Antibody (ANA), Thyroid Stimulating Hormone (TSH)) compared to baseline'}, {'measure': 'Total days of hospitalization after initial dermatology consult', 'timeFrame': '0-120 days', 'description': 'Number of days'}, {'measure': 'Viral reactivation', 'timeFrame': 'Day 30', 'description': 'Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)'}, {'measure': 'Viral reactivation', 'timeFrame': 'Day 60', 'description': 'Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)'}, {'measure': 'Viral reactivation', 'timeFrame': 'Day 90', 'description': 'Measured by titers of Human Herpesvirus 6 (HHV6), Cytomegalovirus (CMV), and Epstein-Barr Virus (EBV)'}, {'measure': 'Mortality', 'timeFrame': 'Day 7', 'description': 'Proportion of patient mortality'}, {'measure': 'Mortality', 'timeFrame': 'Day 30', 'description': 'Proportion of patient mortality'}, {'measure': 'Mortality', 'timeFrame': 'Day 90', 'description': 'Proportion of patient mortality'}, {'measure': '30-day readmission rate', 'timeFrame': 'Day 30', 'description': 'Proportion of patients re-admitted to the hospital within 30 days of discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DRESS Syndrome', 'Drug-Induced Hypersensitivity Syndrome']}, 'descriptionModule': {'briefSummary': 'Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.\n\nThis will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS.\n\nData suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) \\< 30 (unless on dialysis in which case the participants will be included).', 'detailedDescription': 'Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids, cyclosporine and to a lesser extent, intravenous immunoglobulin (IVIG). Regarding IVIG, a recent case series suggests no improved benefit in adults. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis.\n\nThis will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS. Hopefully, this study will allow the investigators to better power a full prospective trial in the future.\n\nThis is a potentially life-threatening severe cutaneous adverse reaction (SCAR) with significant potential morbidity. Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) \\< 30 (unless on dialysis in which case the participants will be included).\n\nParticipants will be randomized using a randomization protocol at all sites. Primary endpoints will include percentage of participants with complete or near complete resolution of organ involvement as well as erythema resolution at day 7 and day 30.\n\nSecondary endpoints will be:\n\n1. fever presence, resolution of facial edema, resolution of pruritus, lymphadenopathy, eosinophil count at days 7 and 30\n2. days of hospitalization\n3. mortality at days 7, 30 and 90\n4. viral reactivation at days 30, 60 and 90\n5. those with autoimmune development by day 30 and day 90\n6. 30 day re-admission rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)\n\nExclusion Criteria:\n\n* Active sepsis\n* Active hepatitis B or C\n* Active tuberculosis\n* Documented allergy to steroids or cyclosporine\n* Estimated glomerular filtration rate (eGFR) \\< 30 (unless on dialysis, in which case they will be included)'}, 'identificationModule': {'nctId': 'NCT04988256', 'briefTitle': 'Cyclosporine Vs Steroids in DRESS', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS', 'orgStudyIdInfo': {'id': 'HS-20-00118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine', 'description': 'All Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO)\n\n1. If complete resolution, stop cyclosporine and monitor closely for relapse\n\n a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days\n\n i. If down-trending, start oral taper regimen\n\n ii. If not down-trending, switch to steroid arm\n2. If \\>25% improvement and labs are down-trending, start the oral taper regimen.\n3. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days\n\n 1. If down-trending, start oral taper regimen\n 2. If not down-trending, switch to steroid arm\n4. If no improvement or up-trending labs at 7 days, switch to steroid arm\n\nOral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days', 'interventionNames': ['Drug: Cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'Corticosteroids', 'description': 'All Patients start with 500 mg IV Methylprednisolone for 3 days\n\n1\\. If \\>25% improvement (must be \\>25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days\n\n1. If no improvement, switch to cyclosporine arm of treatment\n2. If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days\n\ni. If labs are down-trending, start the taper regimen\n\nii. If labs are not down-trending, switch to cyclosporine arm of the study\n\nc. If \\>25% improvement, start the taper regimen\n\nTaper Regimen set as:\n\n1. 125 mg IV Methylprednisolone x3 days\n2. 1.2 mg/kg PO prednisone x1 week\n3. 1 mg/kg PO prednisone x1 week\n4. 0.8 mg/kg PO prednisone x1 week\n5. 0.6 mg/kg PO prednisone x1 week\n6. 0.4 mg/kg PO prednisone x1 week\n7. 0.2 mg/kg PO prednisone x1 week\n8. 0.1 mg/kg PO prednisone x1 week\n9. 0.05 mg/kg PO prednisone x1 week', 'interventionNames': ['Drug: Methylprednisolone and Prednisone']}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Patients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description"', 'armGroupLabels': ['Cyclosporine']}, {'name': 'Methylprednisolone and Prednisone', 'type': 'DRUG', 'description': 'All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.', 'armGroupLabels': ['Corticosteroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Scott Worswick', 'investigatorAffiliation': 'University of Southern California'}}}}