A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Pati
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 (Q
| Condition(s) | Cystic Fibrosis, 10011762 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 \> age ≥ 12 years (2nd cohort), 2. Informed consent of the patient (if applicable) and/or all legal guardians, 3. Sufficient fluency of patient and/or his/her representative in German language to comply with study-specific procedures (e.g. to complete required quality of life questionnaires), 4. Confirmed diagnosis of cystic fibrosis, fulfilling at least one of the following three criteria: 1. sweat chloride ≥ 60mEq/L, 2. two CF causing mutations in the CFTR gene, 3. alterations of transepithelial potential difference of nasal or rectal epithelia typical for CF, 5. FEV1 ≥ 50 % pred. at screening, 6. LCI2.5 ≥ 7.05 at screening, 7. Ability to perform reproducible multiple breath washout and spirometry, 8 |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Heidelberg University |
| Locations | Heidelberg, Baden-Wurttemberg, Germany; Essen, North Rhine-Westphalia, Germany; Berlin, State of Berlin, Germany |
| Start date | 2022-12-01 |
| NCT ID | NCT03925194 |
| Official listing | https://clinicaltrials.gov/study/NCT03925194 |