Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Sarcoidosis; Antimycobacterial Therapy

In brief

The primary purpose of this study is to investigate the efficacy and safety of oral antimycobacterial therapy in patients with confirmed progressive pulmonary sarcoidosis. We suspect that the CLEAR regimen will improve the absolute FVC percent predicted in chronic pulmonary sarcoidosis participants.

Key facts

Study ID

NCT02024555

Run by

Vanderbilt University

People needed

97

Starts

2014-03-01

Expected to finish

2019-04-01

Last updated by the study team

2020-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, as well as biopsy demonstrating granulomas, and no alternative for the cause of the granulomas, such as tuberculosis for at least one year prior to randomization.
• Evidence of disease progression as defined by at least one of the following three criteria:
• Decline of absolute percent predicted of FVC (FVC ≥45% or higher of predicted value) or DLCO of at least 5% on serial measurements (DLCO range >35%, if measured); Radiographic progression in chest imaging on side by side comparison; Change in dyspnea score, as measured by Transition Dyspnea Index (TDI); Positive peripheral immune responses to ESAT-6 as a biomarker of response to CLEAR regimen.
• Possess evidence of parenchymal or nodal disease on chest radiograph.

You may not qualify if…

• Inability to obtain consent
• Age less than 18 years
• Female participants of childbearing potential not willing to use one of the following methods of birth control for the duration of the study and 90 days after study completion: condoms, sponge, foams, jellies, diaphragm, non-hormonal intrauterine device, a vasectomized sole partner or abstinence. Note: Oral contraceptive pills are not effective birth control when taking rifamycin. A negative urine pregnancy test at screening visit if female of childbearing potential
• FVC predicted value is < 45%.
• End-stage fibrotic pulmonary disease.
• Significant underlying liver disease.
• Allergy or intolerance to any of the antibiotics within the CLEAR regimen.
• Allergy or intolerance to albuterol
• Poor venous access for obtaining blood samples
• History of active tuberculosis, close contact with a person with active tuberculosis within the 6 months prior to the screening visit or has a positive PPD.
• Significant disorder, other than sarcoidosis, that would complicate the treatment evaluation, (such as respiratory, cardiac, neurologic, musculoskeletal or seizure disorders)
• Use of an investigational drug within 30 days prior to screening or within 5 half-lives of the agent, whichever is longer.
• Currently receiving >40mg prednisone.
• ALT or AST >5 times upper limit of normal (ULN)
• Leukopenia, as defined by WBC <3.0 cells/mm3 or absolute neutrophil count <1000
• Breast feeding.
• Color perception impairment as defined by the inability to differentiate colors per personal history or history of optic neuritis from any cause, including from sarcoidosis.
• If patient is on immunomodulators, they must be on regimen for ≥ 3-month period and on a stable dose for > 4 weeks.
• Family or personal history of long QT interval
• Most recent nuclear medicine scan or echocardiogram (if done), demonstrating cardiac ejection fraction <35%
• Participant has persistent or active infection(s) requiring hospitalization or treatment with antibiotics, antiretrovirals, or antifungals within 30 days prior to baseline. Minocycline and doxycycline are not considered antibiotics when used to treat sarcoidosis.
• Any significant finding in the patient's medical history or physical or psychiatric exam prior to or after randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol.
• On medications that interact with the antibiotics of the CLEAR regimen
• History of or receiving treatment for pulmonary hypertension. Receiving biologic medication within the 6 months prior to screening visit

Where it is running

• Albany Medical Center — Albany, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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