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

NCT03925194 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-03-27

No results posted yet for this study

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

DRUG

Anakinra

Application of Anakinra once daily for 28 days

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925194 on ClinicalTrials.gov