Cystic Fibrosis, 10011762Phase 2ANAKINNCT03925194
A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF
A Phase 2 study testing Anakinra in people with Cystic Fibrosis, 10011762, run by Heidelberg University at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis, 10011762
- What is being tested?
- Anakinra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Dec 2022to 25 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 > age ≥ 12 years (2nd cohort),
- Informed consent of the patient (if applicable) and/or all legal guardians,
- 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),
- Confirmed diagnosis of cystic fibrosis, fulfilling at least one of the following three criteria:
- sweat chloride ≥ 60mEq/L,
- two CF causing mutations in the CFTR gene,
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- alterations of transepithelial potential difference of nasal or rectal epithelia typical for CF,
- FEV1 ≥ 50 % pred. at screening,
- LCI2.5 ≥ 7.05 at screening,
- Ability to perform reproducible multiple breath washout and spirometry,
- Oxyhaemoglobin saturation of ≥ 90% on room air at screening,
- 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),
- 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,
- Adequate liver function assessed on the basis of: GGT, ASAT, and ALAT <3 x upper limit of normal (ULN),
- Adequate blood clotting assessed on the basis of: aPTT <39 sec., INR <1.2,
- 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,
- 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)),
- Use of adequate contraception in sexually active female subjects (sexual abstinence, hormonal contraceptives or intrauterine device).
Who cannot join
- Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures,
- Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,
- 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,
- Renal failure (creatinine in serum above ULN),
- History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months before start of each treatment period,
- History of detection of Burkholderia cenocepacia species in the last 12 months before start of each treatment period,
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- 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,
- 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,
- 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),
- 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,
- Participation in another interventional trial within the last 30 days prior to screening,
- Current oral corticosteroid use,
- Current oxygen supplementation,
- Current treatment with etanercept,
- Medical history of lung transplantation,
- Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening),
- Known hypersensitivity to hypertonic saline (used for induction of sputum).
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Universitätsmedizin Essen, Ruhrlandklinik
Essen, North Rhine-Westphalia, 45239
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: 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
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
- Being tested
- Anakinra
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Application of Anakinra once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Not described Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Not described Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute pre-post change of the lung clearance index (LCI)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Dec 2022
- Primary completion30 Jun 2025
- Study completion25 Jul 2025
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis, 10011762Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Stahl, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925194
- Sponsor's protocol ID
- EudraCT No.: 2016-004786-80-A
- Acronym
- ANAKIN
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03925194
- Acronym / sponsor ID
- ANAKIN / EudraCT No.: 2016-004786-80-A
- Conditions
- Cystic Fibrosis, 10011762
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding issues
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra |
| Placebo | Placebo comparator | Drug: Anakinra |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 > age ≥ 12 years (2nd cohort),
- Informed consent of the patient (if applicable) and/or all legal guardians,
- 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),
- Confirmed diagnosis of cystic fibrosis, fulfilling at least one of the following three criteria:
- FEV1 ≥ 50 % pred. at screening,
Key exclusion criteria (17 listed)
- Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures,
- Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,
- 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,
- Renal failure (creatinine in serum above ULN),
- History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months before start of each treatment period,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraApplication of Anakinra once daily for 28 days | Drug | Anakinra, Placebo |
Primary outcome
Absolute pre-post change of the lung clearance index (LCI)
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra in people with Cystic Fibrosis, 10011762, run by Heidelberg University at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute pre-post change of the lung clearance index (LCI) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.