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RECRUITING
NCT03925194
PHASE2

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

Sponsor: Heidelberg University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2022-12-01

Completion Date

2026-12-01

Last Updated

2025-03-27

Healthy Volunteers

No

Interventions

DRUG

Anakinra

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