NCT03925194

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis, 10011762

Interventions

Type	Name	Description
DRUG	Anakinra	Application of Anakinra once daily for 28 days

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-04-24
• Last updated: 2025-03-27

Locations

3 sites across 1 country: Germany