Image

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

Join a study on MNKD-101, an inhaled treatment for respiratory issues.

Recruiting
18-85 years
All
Phase 3

This study is testing a medicine called **Clofazimine Inhalation Suspension**. It's for people with lung problems like bronchiectasis, where the lungs get damaged and struggle to clear mucus. The study compares this medicine to a placebo, which is a fake treatment with no medicine in it. It aims to see if Clofazimine can help improve lung health and life quality.

Participants will first join a **randomized, double-blind, placebo-controlled** part, meaning neither they nor the doctors know who gets the real medicine or the placebo. If eligible, participants may continue to receive the real medicine in an **open-label extension**, where everyone knows they're getting the actual treatment.

  • The study is for adults aged 18-85 years.
  • Participants must have certain lung conditions and agree to regular visits and tests.
  • Exclusion includes conditions like cystic fibrosis, active tuberculosis, or recent heart problems.

Participants will need to follow guidelines, possibly adjust their current treatments, and ensure no recent trial participation or certain medication use. The goal is to find out if Clofazimine can be a safe and effective addition to existing treatments for lung infections.

Study details
    MAC Lung Disease
    Treatment Refractory MAC Lung Disease
    Mycobacterium Infections
    Nontuberculous

NCT06418711

Mannkind Corporation

8 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.