RecruitingPhase 2NCT03925194

A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF

A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis


Sponsor

Heidelberg University

Enrollment

52 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

OBJECTIVES Primary: To evaluate efficacy of treatment with anakinra in subjects with CF who are ≥ 12 years of age by means of lung clearance index (LCI). Secondary To evaluate safety and tolerability of treatment with anakinra as well as to investigate further effects of anakinra on lung function and quality of life (QOL) in subjects with CF.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anakinra for people with cystic fibrosis, 10011762. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnakinra

Application of Anakinra once daily for 28 days


Locations(3)

University Children's Hospital Heidelberg, Cystic Fibrosis Centre

Heidelberg, Baden-Wurttemberg, Germany

Universitätsmedizin Essen, Ruhrlandklinik

Essen, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

View Full Details on ClinicalTrials.gov

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NCT03925194