drugset / Trial / NCT03925194

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

NCT03925194

Phase 2 Recruiting 52 enrolled Heidelberg University
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2022-12-01
Primary completion
2026-12-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic Subcutaneous

Indications