About the Study

ICoN-1 is a research study that evaluates the efficacy and safety of Clofazimine Inhalation Suspension on top of guideline-based therapy (GBT). The study is for adults with Nontuberculous Mycobacteria (NTM) lung disease caused by a bacteria known as mycobacterium avium complex (MAC). 

Find a US study location near you

This information is for the United States (US). If you live outside of the US, refer to your local regulatory authority for more information. 

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About NTM and the Study Drug

What is NTM?

NTM, or nontuberculous mycobacteria, are bacteria naturally found in water and soil that may cause a lung infection. NTM lung infection happens when a person breathes in the bacteria. Most people who come across these bacteria do not get ill. A progressive disease can develop for some people, especially those with compromised lung health or other risk factors. People with chronic lung disease or those that are immunocompromised have a higher risk of infection.

Understanding Clofazimine Inhalation Suspension

Clofazimine Inhalation Suspension (study drug) is an antibiotic in development by MannKind. It is being studied for the treatment of NTM lung disease. The medication is inhaled through the mouth and delivered directly to the lungs. This allows it to target the location of the infection. It has not been approved by any health authority in the world and its safety and efficacy have not been confirmed. 

To read Important Safety Information, click here.

To explore the MannKind’s mission, click here.

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Who can join?

You must:

  • Be between ages 18-85
  • Have the ability to produce approximately 3mL of sputum
  • Be diagnosed with NTM lung disease
  • Be able to inhale with a nebulizer
  • Be currently taking medication for NTM

You must not:

  • Have active lung cancer
  • Have any malignancy requiring chemotherapy or radiation therapy in the past 3 years or during the study
  • Be pregnant, breastfeeding, or plan to become pregnant during the study
  • Use bedaquiline within 1 year of screening

The information above is not a complete list. You can review a more complete list on ClinicalTrials.gov A study doctor will review the full list of requirements to determine if you qualify.

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Who

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What’s involved in this study?

  • Procedures that include in person and phone visits, blood draws, sputum samples, lung function tests, electrocardiogram (ECG), and questionnaires
  • Study medication or placebo that is self-administered for one month followed by two months of no study medication or placebo, this cycle repeats at least once
  • At-home inhalation of study medication or placebo using a nebulizer that delivers medication directly into the lungs
  • The main part of the study is about 6-7 months long and participants receive study medication or placebo
  • The second part is up to 18 months long and all eligible participants receive study medication
  • The final part is a 12-month follow up after eligible participants are off the study medication
Find a US study location near you
What

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Study Locations

Over 50 US sites are expected with additional sites worldwide. Use the filter below to find the US site closest to you. Simply put your ZIP code in below and click “SEARCH” to get started.

      Locations

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      Frequently Asked Questions

      The following are frequently asked questions (FAQs) about ICoN-1 or clinical studies in general. Click on the questions below to see the responses.

      Overview Questions

      ICoN-1 Study Specific Questions

      FAQs
      Resources

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      Resources

      For more resources and information, visit ClinicalTrials.gov. 
      Other key resources for learning about NTM include:

      ISI

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      Important Safety Information

      • Clofazimine Inhalation Suspension is an antibiotic that is breathed-in through your lungs (inhaled). It has not been approved by any health authority in the world. It is being studied for the treatment of Non-tuberculous Mycobacteria (NTM) lung disease in adults.
        • NTM lung disease is a rare lung disease caused by bacteria found naturally in soil and water. If you have a weak immune system or are living with a chronic lung disease, you are at a higher risk of infection.
      • Clofazimine Inhalation Suspension has been tested in healthy volunteers in a clinical study. The most common adverse events were: 
        • Disorders in/around the chest and lungs (such as mild nosebleeds, cough, throat or respiratory tract irritation, nasal discharge discoloration),
        • Disorders of the stomach or intestines,
        • Nervous system disorders (such as headache and dizziness),
        • Infections (such as common colds or other viral infection).

      None of the events related to Clofazimine Inhalation Suspension were serious.

      • Oral clofazimine can cause skin discoloration and an irregular heartbeat. These risks have not been ruled out with Clofazimine Inhalation Suspension. There may be other risks or side effects that are unknown.
      • Do not join the study if you are allergic to the ingredients of Clofazimine Inhalation Suspension including saline and/or Polysorbate 80. Allergic reactions may include rash, fast heartbeat, sweating, hives, itching, difficulty breathing, wheezing, convulsions, loss of consciousness and possibly death.
      • Do not join the study at this time if you have used amikacin (inhaled or IV) in the past 2 months or currently on amikacin.
      • Do not join the study if you are pregnant, breast-feeding or plan to become pregnant.
      • The purpose of the ICoN-1 study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from your lungs and to make sure that it is safe for use in adults 18-85 years of age.

      Interested in learning more?

      To learn if you qualify, talk with your doctor or reach out to a clinical site near you.

      Find a US study location near you

      For more information, visit ClinicalTrials.gov.