Testing an injection treatment for lung health in cystic fibrosis

Plain-English translation of NCT03925194 on ClinicalTrials.gov ↗ · Source last updated March 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether , a medication given by injection under the skin, can help improve lung function in people with cystic fibrosis. The study will compare this medication to a placebo (a dummy injection with no active drug) to see if the treatment is safe and actually works. About 52 people will participate in this research conducted at Heidelberg University.

Cystic fibrosis damages the lungs over time, and current treatments don't work for everyone. This medication works by reducing inflammation in the lungs, and researchers hope it may slow down lung damage and improve breathing in people living with this condition.

Do you qualify?

You likely qualify if…

you are at least 18 years old (or at least 12 years old in a second part of the study, if initial results support it)
you have been diagnosed with cystic fibrosis confirmed by genetic testing or sweat chloride test
your lung function is at least 50% of what is expected for your age and size
you have not changed your regular cystic fibrosis medications for at least 4 weeks before the study starts
your blood work shows healthy liver, kidney, and blood cell counts
you are willing to use reliable birth control if you are a woman who can become pregnant

You likely don't qualify if…

you are allergic to anakinra or any ingredient in the medication
you have had tuberculosis or certain other serious lung infections in the past year
you have severe kidney problems
you have drug-resistant bacteria (MRSA or resistant Pseudomonas) in your lungs
you are planning to receive a live vaccine or received one within the past 4 weeks

What participation looks like

You would receive injections of either the new medication or a placebo under your skin during two separate treatment periods. The study uses a "crossover" design, meaning everyone gets a chance to try both the real medication and the placebo at different times. Between treatment periods, there will be a washout phase to let your body return to baseline. Throughout the study, you will have lung function tests, blood work, and quality-of-life questionnaires to help researchers understand how the treatment affects you.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(3 sites)

Germany

University Children's Hospital Heidelberg, Cystic Fibrosis Centre, Heidelberg, Baden-Wurttemberg

Universitätsmedizin Essen, Ruhrlandklinik, Essen, North Rhine-Westphalia

Charité - Universitätsmedizin Berlin, Berlin, State of Berlin