NCT03925194 (ANAKIN) is a Phase 2 clinical trial of Anakinra in Cystic Fibrosis, 10011762, sponsored by Heidelberg University.

Who is sponsoring NCT03925194?

NCT03925194 is sponsored by Heidelberg University.

What drugs are being tested in NCT03925194?

Interventions in NCT03925194: Anakinra.

What condition does NCT03925194 study?

NCT03925194 studies Cystic Fibrosis, 10011762.

Is NCT03925194 still recruiting?

NCT03925194 is currently recruiting now. Last updated 27 March 2025.

Last reviewed 2025-03-27 · How we verify

NCT03925194: ANAKIN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 27 March 2025

What this trial tests

Phase 2 trial testing Anakinra in Cystic Fibrosis, 10011762 in 52 participants. Currently enrolling.

Timeline

1 December 2022

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Heidelberg University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	52
Start date	1 December 2022
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	3 locations across Germany

Drugs / interventions tested

Anakinra (ANAKINRA) — full drug profile →

Conditions studied

Cystic Fibrosis, 10011762 — all drugs for Cystic Fibrosis, 10011762 →

Sponsor

Heidelberg University

Who can join

12 and older, any sex, with Cystic Fibrosis, 10011762. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Neutrophil diversity and function in health and disease.
Zhang F, Xia Y, Su J, Quan F, et al · · 2024 · cited 109× · PMID 39638788 · DOI 10.1038/s41392-024-02049-y
Mitochondrial Stress Responses and "Mito-Inflammation" in Cystic Fibrosis.
Patergnani S, Vitto VAM, Pinton P, Rimessi A. · · 2020 · cited 20× · PMID 33101035 · DOI 10.3389/fphar.2020.581114
Therapeutic and diagnostic targeting of fibrosis in metabolic, proliferative and viral disorders.
Sofias AM, De Lorenzi F, Peña Q, Azadkhah Shalmani A, et al · · 2021 · cited 17× · PMID 34139255 · DOI 10.1016/j.addr.2021.113831
Off-label therapy targeting pathogenic inflammation in COVID-19.
Romani L, Tomino C, Puccetti P, Garaci E. · · 2020 · cited 17× · PMID 32547788 · DOI 10.1038/s41420-020-0283-2
Anakinra restores cellular proteostasis by coupling mitochondrial redox balance to autophagy.
van de Veerdonk FL, Renga G, Pariano M, Bellet MM, et al · · 2022 · cited 15× · PMID 34847078 · DOI 10.1172/jci144983

Verify or expand the search:

Other trials of Anakinra

Trials testing the same drug.

NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
NCT07281027 — COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" · Phase 3 · not yet recruiting
NCT07191444 — A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease · recruiting
NCT06666335 — A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF · Phase 4 · not yet recruiting
NCT06697431 — Non Inferiority KawasakI Trial With Anakinra · Phase 4 · not yet recruiting

Other Heidelberg University trials

Trials by the same sponsor.

NCT07106294 — Hyperspectral Imaging for Prediction of Preeclampsia · recruiting
NCT06651164 — Psychosomatic Risk Screening · NA · completed
NCT07378345 — Optimization of Communication Between Surgery and Pathology · NA · completed
NCT06018272 — Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany · NA · recruiting
NCT06852599 — Long-term Outcomes of Implants in Patients with Periodontitis · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03925194 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Heidelberg University
Last refreshed: 27 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03925194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing