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Use of CXCL9 as a Biomarker of Acthar Efficacy (Acthar)

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ClinicalTrials.gov Identifier: NCT02523092
Recruitment Status : Not yet recruiting
First Posted : August 14, 2015
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Laura L. Koth, MD, University of California, San Francisco

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Acthar gel Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of CXCL9 as a Biomarker of Acthar Efficacy
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: Acthar gel
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.
Drug: Acthar gel
Acthar gel given IM or SQ as per package insert
Other Name: Acthar




Primary Outcome Measures :
  1. Decrease in blood CXCL9 levels by 50% [ Time Frame: within 6 months ]

Secondary Outcome Measures :
  1. Improvement in FVC by 5% of predicted [ Time Frame: within 6 months ]
  2. Improvement in dyspnea score [ Time Frame: within 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523092


Contacts
Contact: Zoe Lehman, BA 415-476-9637 zoe.lehman@ucsf.edu
Contact: Laura Koth, MD 415-514-4369 laura.koth@ucsf.edu

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Laura Koth, MD    415-514-4369    laura.koth@ucsf.edu   
Principal Investigator: Laura Koth, MD         
Sponsors and Collaborators
University of California, San Francisco
Mallinckrodt
Investigators
Principal Investigator: Laura Koth, MD University of California, San Francisco

Additional Information:
Publications:
Responsible Party: Laura L. Koth, MD, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02523092     History of Changes
Other Study ID Numbers: 15-17300
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Laura L. Koth, MD, University of California, San Francisco:
sarcoidosis
Acthar
CXCL9
chemokine ligand 9

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs