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

Q: Who can participate in NCT03925194?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT03925194?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF (NCT03925194) is a Phase 2 interventional studying Cystic Fibrosis, 10011762, sponsored by Heidelberg University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cystic Fibrosis, 10011762 and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 52 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cystic Fibrosis, 10011762 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 \> age ≥ 12 years (2nd cohort), 2. willing to sign a consent form 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. Oxyhaemoglobin saturation of ≥ 90% on room air at screening, 9. No changes in the medication for cystic fibrosis lung disease for at least 4 weeks prior to the first administration of the IMP of each treatment period (in case of medication changes in Period 1 and/or the washout phase the wash-out may be extended for up to 12 weeks in order to fulfill this criterion), 10. Adequate bone marrow function assessed on the basis of: neutrophils \>1.5 x 109/L, platelets \>100 x 109/L, hemoglobin \>9.0 g/dL, 11. Adequate liver function assessed on the basis of: GGT, ASAT, and ALAT \<3 x upper limit of normal (ULN), 12. Adequate blood clotting assessed on the basis of: aPTT \<39 sec., INR \<1.2, 13. Negative serology for HIV (anti-HIV 1/2 IgG/IgM and p24-Ag), HBV (anti-HBs quantitative and anti-HBc IgG/IgM) and HCV (anti-HCV IgG), negative Interferon-gamma release assay, 14. Negative Beta-HCG blood/urine test in women of childbearing potential (of childbearing potential are females who have experienced menarche and are not permanently sterile or postmenopausal (postmenopausal: 12 consecutive months with no menses without an alternative medical cause)), ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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. Oxyhaemoglobin saturation of ≥ 90% on room air at screening, 9. No changes in the medication for cystic fibrosis lung disease for at least 4 weeks prior to the first administration of the IMP of each treatment period (in case of medication changes in Period 1 and/or the washout phase the wash-out may be extended for up to 12 weeks in order to fulfill this criterion), 10. Adequate bone marrow function assessed on the basis of: neutrophils \>1.5 x 109/L, platelets \>100 x 109/L, hemoglobin \>9.0 g/dL, 11. Adequate liver function assessed on the basis of: GGT, ASAT, and ALAT \<3 x upper limit of normal (ULN), 12. Adequate blood clotting assessed on the basis of: aPTT \<39 sec., INR \<1.2, 13. Negative serology for HIV (anti-HIV 1/2 IgG/IgM and p24-Ag), HBV (anti-HBs quantitative and anti-HBc IgG/IgM) and HCV (anti-HCV IgG), negative Interferon-gamma release assay, 14. Negative Beta-HCG blood/urine test in women of childbearing potential (of childbearing potential are females who have experienced menarche and are not permanently sterile or postmenopausal (postmenopausal: 12 consecutive months with no menses without an alternative medical cause)), 15. Use of adequate contraception in sexually active female subjects (sexual abstinence, hormonal contraceptives or intrauterine device). Exclusion Criteria: 1. Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures, 2. Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®, 3. Planned immunization with attenuated (live) vaccine(s) during the treatment with the IMP or completed immunization with attenuated (live) vaccine(s) within 4 weeks prior to the first administration of the IMP, 4. Renal failure (creatinine in serum above ULN), 5. History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months before start of each treatment period, 6. History of detection of Burkholderia cenocepacia species in the last 12 months before start of each treatment period, 7. Colonization with multi-resistant Staphylococcus aureus (MRSA) and/or 4-multi-resistant gram negative (MRGN) Pseudomonas aeruginosa is only an exclusion criterion if the treating physician judges that this is an increased risk for the patient, 8. Acute bronchopulmonary exacerbation (defined by modified Fuchs criteria (1) (see Appendix 1), modification includes all ways of application of an antibiotic (e.g., oral, i.v., inhaled)) within 14 days prior to the screening and before start of each treatment period, 9. Signs of other active infection within 14 days prior to the screening and before start of each treatment period (clinical symptoms (e.g. burning sensation while urinating, skin, wound or dental infection) and/or fever and/or deterioration of infection-specific laboratory parameters beyond changes driven by the underlying disease), 10. Immunosuppressive treatment due to organ transplantation, rheumatic or autoimmune diseases as well as treatment with Anakinra in the last 3 months before Day 1 of Period 1, 11. Participation in another interventional trial within the last 30 days prior to screening, 12. Current oral corticosteroid use, 13. Current oxygen supplementation, 14. Current treatment with etanercept, 15. Medical history of lung transplantation, 16. Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening), 17. Known hypersensitivity to hypertonic saline (used for induction of sputum).

Treatments Being Tested

DRUG

Anakinra

Application of Anakinra once daily for 28 days

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03925194), the sponsor (Heidelberg University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03925194 clinical trial studying?

Who can participate in NCT03925194?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03925194?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03925194. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03925194. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.