Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Mycobacterium Avium Complex

In brief

The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD

Key facts

Study ID

NCT02968212

Run by

Oregon Health and Science University

People needed

102

Starts

2017-04-11

Expected to finish

2026-10-01

Last updated by the study team

2026-05-06

Who can join

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

You may qualify if…

• At least 2 positive MAC sputum cultures in the last 12 months with at least one obtained within 12 weeks prior to randomization
• Meet ATS/IDSA 2007 pulmonary disease criteria
• Adult males and females age 18 or over
• Ability to provide informed consent for the use of study drug

You may not qualify if…

• Any patient who is unwilling or unable to provide consent or to comply with this protocol
• Cavitary NTM disease
• Patients who are currently taking or within the prior 12 weeks received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC
• Current usage of inhaled amikacin, tobramycin, or gentamicin
• In the judgment of the investigator, the patient is not a candidate for observation (e.g. severe symptoms, extensive disease burden) but rather should be treated with standard multi-drug therapy
• Prior use of clofazimine that has resulted in an allergy to clofazimine or a severe adverse reaction
• Current usage of medications associated with QT prolongation (see Appendix C for full list of prohibited concomitant medications)
• Corrected QT (QTc) interval on electrocardiogram (ECG) > 470 ms for females or 450 ms for males, calculated using Fridericia's formula60,61
• Advanced lung disease (FEV<30%)
• HIV
• Active pulmonary tuberculosis requiring treatment at screening
• Active pulmonary malignancy or chemotherapy or radiation within 1 year of screening
• Use of chronic systemic corticosteroids at doses of 15 mg/day for more than 12 weeks
• Prior lung or other solid organ transplant
• Pregnancy, or breastfeeding that will continue during treatment

Where it is running

• National Jewish Health — Denver, Colorado, United States
• University of South Florida — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Louisiana State University — Baton Rouge, Louisiana, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Texas Health Science Center — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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