Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02523092
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of CXCL9 as a Biomarker of Acthar Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in blood CXCL9 levels by 50%', 'timeFrame': 'within 6 months'}], 'secondaryOutcomes': [{'measure': 'Improvement in FVC by 5% of predicted', 'timeFrame': 'within 6 months'}, {'measure': 'Improvement in dyspnea score', 'timeFrame': 'within 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcoidosis', 'Acthar', 'CXCL9', 'chemokine ligand 9'], 'conditions': ['Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '25142485', 'type': 'BACKGROUND', 'citation': 'Su R, Li MM, Bhakta NR, Solberg OD, Darnell EP, Ramstein J, Garudadri S, Ho M, Woodruff PG, Koth LL. Longitudinal analysis of sarcoidosis blood transcriptomic signatures and disease outcomes. Eur Respir J. 2014 Oct;44(4):985-93. doi: 10.1183/09031936.00039714. Epub 2014 Aug 19.'}], 'seeAlsoLinks': [{'url': 'http://sarcoidosis.ucsf.edu/', 'label': 'Homepage for the Sarcoidosis Research Program at the University of California, San Francisco'}]}, 'descriptionModule': {'briefSummary': 'The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).', 'detailedDescription': "The investigators will test whether Acthar gel's anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement\n* Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate\n\nExclusion Criteria:\n\n* Smoking\n* Cancer\n* Chronic infections (e.g. tuberculosis, viral, fungal, bacterial)\n* Inflammatory conditions\n* Coexisting lung disease\n* Congestive heart failure\n* Uncontrolled hypertension\n* Recent surgery\n* Active peptic ulcers\n* Osteoporosis'}, 'identificationModule': {'nctId': 'NCT02523092', 'acronym': 'Acthar', 'briefTitle': 'Use of CXCL9 as a Biomarker of Acthar Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Use of CXCL9 as a Biomarker of Acthar Efficacy', 'orgStudyIdInfo': {'id': '15-17300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acthar gel', 'description': 'After a 4-week period of baseline monitoring, Acthar gel will be administered by intramuscular or subcutaneous injection. Initial dosing will be 40 U every 72 hours (or twice per week) for 4 weeks. Dosage will then be increased to 80 U with similar frequency for 8 weeks and up to 16 weeks.', 'interventionNames': ['Drug: Acthar gel']}], 'interventions': [{'name': 'Acthar gel', 'type': 'DRUG', 'otherNames': ['Acthar'], 'description': 'Acthar gel given IM or SQ as per package insert', 'armGroupLabels': ['Acthar gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Koth, MD', 'role': 'CONTACT', 'email': 'laura.koth@ucsf.edu', 'phone': '415-514-4369'}, {'name': 'Laura Koth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Laura Koth, MD', 'role': 'CONTACT', 'email': 'Laura.Koth@ucsf.edu', 'phone': '(415) 514-4369'}], 'overallOfficials': [{'name': 'Laura Koth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}