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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized, Double-Blinded, Placebo-Controlled, Phase II Inhaled Interferon Gamma-1b and Antimycobacterials to Treat Pulmonary Mycobacterium Avium Complex Infections

NCT00021567

Mycobacterium Avium-Intracellulare Infection

COMPLETED PHASE2

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

NCT06418711

MAC Lung Disease Treatment Refractory MAC Lung Disease Mycobacterium Infections, Nontuberculous

TERMINATED PHASE3

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

NCT05496374

Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

COMPLETED PHASE2

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

NCT02024555

Sarcoidosis; Antimycobacterial Therapy

COMPLETED PHASE2

Comparative Effectiveness and Safety of Inhaled Corticosteroids and Antimicrobial Compounds for Non-CF Bronchiectasis

NCT02714283

Bronchiectasis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Clofazimine is an orphan antibiotic drug that is no longer available through pharmacies in the United States. It is approved for the treatment of Mycobacterium leprae (leprosy) infections. Clofazimine has been used for many years off-label against other Mycobacterium, including Mycobacteria avium complex (MAC) lung disease, an increasingly prevalent infection in older Americans. The U.S. Food and Drug Administration currently oversees clofazimine use to treat MAC lung disease through a special investigational drug access program. However, to date, there is little understanding of the benefits and risks of clofazimine when used to treat MAC lung disease. Accordingly, the investigators have developed a randomized, placebo-controlled clinical trial to assess the clinical efficacy and safety of clofazimine. To be eligible, participants must have MAC lung disease, positive sputum cultures for MAC, and not currently taking antibiotics for MAC. Eligible participants (102 total enrolled) will be randomly given either clofazimine or placebo for 6 months, and followed closely by their treating physician. The percentage of participants who become culture negative in each group will be compared, as it is suspected that participants treated with clofazimine will be more likely to become culture negative. The safety of clofazimine will be measured as well as other potential benefits of the therapy including changes in lung function and quality of life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycobacterium Avium Complex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

clofazimine

Participants receive lamprene

Group Type EXPERIMENTAL

Clofazimine

Intervention Type DRUG

All participants in the experimental/treatment arm on this protocol will take a loading dose of 200 mg daily in soft capsule form of clofazimine for 16 weeks, dropping to 100 mg daily for the next 8 weeks.

sugar pill

Participants receive placebo

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type OTHER

All participants in the placebo arm on this protocol will take placebo in soft capsule form daily dropping to a smaller dose after 16 weeks to mirror the treatment arm dosing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clofazimine

All participants in the experimental/treatment arm on this protocol will take a loading dose of 200 mg daily in soft capsule form of clofazimine for 16 weeks, dropping to 100 mg daily for the next 8 weeks.

Intervention Type DRUG

sugar pill

All participants in the placebo arm on this protocol will take placebo in soft capsule form daily dropping to a smaller dose after 16 weeks to mirror the treatment arm dosing.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lamprene placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No