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Clinical trial

Use of CXCL9 as a Biomarker of Acthar Efficacy

ID
Name
15-17300
Description
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).
Trial arms
Trial start
2022-11-03
Estimated PCD
2025-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Acthar gel
Acthar gel given IM or SQ as per package insert
Arms:
Acthar gel
Other names:
Acthar
Size
14
Primary endpoint
Decrease in blood CXCL9 levels by 50%
within 6 months
Eligibility criteria
Inclusion Criteria: * Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement * Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate Exclusion Criteria: * Smoking * Cancer * Chronic infections (e.g. tuberculosis, viral, fungal, bacterial) * Inflammatory conditions * Coexisting lung disease * Congestive heart failure * Uncontrolled hypertension * Recent surgery * Active peptic ulcers * Osteoporosis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ESTIMATED'}}
Updated at
2023-05-11

1 organization

1 product

1 indication

Organization
University of California, San Francisco
Product
Acthar
Indication
Sarcoidosis