Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:34 PM
Study NCT ID:
NCT07486869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'C538250', 'term': 'Amyopathic dermatomyositis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000644327', 'term': 'Emapalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in oxygen requirement', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Supplemental oxygen requirement assessed as the oxygen flow rate (reported in liters per minute \\[L/min\\]) while the participant is at rest and, when feasible, while the participant is ambulating during the 6-Minute Walk Test (6MWT). Values are compared with baseline to assess change over time.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV₁)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Pulmonary function assessed using forced expiratory volume in 1 second (FEV₁) measured by standard pulmonary function testing (spirometry). The outcome is expressed as percent change from baseline (%) in FEV₁.'}, {'measure': 'Diffusing capacity of the lungs for carbon monoxide (DLCO)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Pulmonary gas exchange capacity assessed using diffusing capacity of the lungs for carbon monoxide (DLCO) measured by standard pulmonary function testing. The outcome is expressed as percent change from baseline (%) in DLCO'}, {'measure': 'Change in chest computed tomography (CT) consolidations', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Pulmonary consolidations assessed on chest computed tomography (CT) scans. CT images are reviewed by a radiologist and pulmonologist, and percentage of lung affected by consolidations will be documented. Percentage change of affected lung will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Change in Ferritin level', 'timeFrame': 'Baseline, 4 weeks, 12 weeks', 'description': 'Serum ferritin concentration measured using standard clinical laboratory testing and reported in nanograms per milliliter (ng/mL). Values obtained at baseline and during post-baseline assessments are used to assess change from baseline in ferritin level.'}, {'measure': 'Change in MDA5 antibody level', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Serum anti-melanoma differentiation-associated protein 5 (anti-MDA5) antibody level measured as a quantitative serum laboratory value using a validated clinical assay. Values obtained at baseline and during post-baseline assessments are used to assess change from baseline in serum anti-MDA5 antibody level.'}, {'measure': 'New infections during treatment', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Number of participants who experience at least one new infection during the study period, as identified through clinical assessment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatomyositis', 'Dermatomyositis Sine Myositis', 'Dermatomyositis With Myopathy', 'Dermatomyositis With Respiratory Involvement', 'Dermatomyositis With Organ Involvement', 'Interstitial Lung Disease', 'Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)']}, 'descriptionModule': {'briefSummary': 'This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial lung disease (MDA5 RP-ILD). Emapalumab is a medication that is currently used for a severe problem with the immune system, called macrophage activation syndrome, and this disease shares some similar features with MDA5 RP-ILD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Progressive interstitial lung disease as determined by at least 2/4 of the following:\n\n 1. worsening respiratory symptoms;\n 2. worsening or new oxygen requirement;\n 3. worsening disease on CT chest;\n 4. worsening Forced Vital Capacity (FVC1) or Diffusing Capacity for Carbon Monoxide (DLCO) on pulmonary function tests\n* MDA5 antibodies present\n* Elevated ferritin above the upper limit of normal (ULN)\n* Participant at least 18 years old\n\nExclusion Criteria:\n\n* Active, untreated bacterial, mycobacterial or fungal infection\n* Active herpes zoster infection\n* Currently requiring extracorporeal membrane oxygenation (ECMO)\n* Participant refusal to participate in the study\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT07486869', 'briefTitle': 'Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Emapalumab for the Treatment of Anti-MDA5 Antibody Positive Rapidly Progressive Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '20241227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emapalumab', 'description': 'Participants will receive emapalumab administered intravenously at a dose of 6 mg/kg on Day 1, followed by 3 mg/kg every 3 days for 2 weeks, and then 3 mg/kg twice weekly for an additional 2 weeks. Total treatment duration is 12 weeks.', 'interventionNames': ['Drug: Emapalumab']}], 'interventions': [{'name': 'Emapalumab', 'type': 'DRUG', 'description': 'Emapalumab administered intravenously according to the following dosing regimen: 6 mg/kg on Day 1, followed by 3 mg/kg every 3 days for 2 weeks, and then 3 mg/kg twice weekly for 2 weeks.', 'armGroupLabels': ['Emapalumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Kelly Corbitt, D.O.', 'role': 'CONTACT', 'email': 'KKC51@miami.edu', 'phone': '305-243-7545'}], 'facility': 'University of Miami Hospital and Clinics', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Kelly Corbitt, D.O.', 'role': 'CONTACT', 'email': 'KKC51@miami.edu', 'phone': '305-243-7545'}], 'overallOfficials': [{'name': 'Kelly Corbitt, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Orphan Biovitrum AB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Medicine', 'investigatorFullName': 'Kelly Corbitt', 'investigatorAffiliation': 'University of Miami'}}}}