72 completed, 16 terminated, 11 recruiting, 10 unknown. 72 Phase 2, 34 Phase 1, 26 Phase 3, 8 Not applicable, 5 Phase 4.
Follow Anakinra: new trials by email Literature Review of Anakinra trials Research Report on Anakinra
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" Anakinra, Tocilizumab, Standard medical treatment - New Onset Refractory Status Epilepticus, New-Onset Refractory Status Epilepticus | Phase 3 | Not yet recruiting | Yale University | 438 | 2026-12-01 | 2026-08-19 |
| Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or Older Anakinra, Biospecimen Collection, Computed Tomography - Melanoma | Phase 1 | Not yet recruiting | University of Southern California | 40 | 2026-11-01 | 2026-09-24 |
| Anakinra for Prevention of Poor Graft Function in MDS Allo-HSCT Anakinra - Poor Graft Function, Myelodysplastic Syndromes | Phase 1 / Phase 2 | Not yet recruiting | Ruijin Hospital | 66 | 2026-10-05 | 2026-10-22 |
| BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction Anakinra - Lung Transplant Recipient | Early Phase 1 | Not yet recruiting | Northwestern University | 20 | 2026-10-01 | 2026-08-21 |
| Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial Tocilizumab, Baricitinib, Anakinra - Sepsis | Phase 2 | Recruiting | Assistance Publique - Hôpitaux de Paris | 2000 | 2026-07-09 | 2026-10-20 |
| A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF Anakinra - Familial Mediterranean Fever (FMF ) | Phase 4 | Withdrawn | Swedish Orphan Biovitrum | 2026-03-01 | 2026-06-29 | |
| Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty Methotrexate, Sulfasalazine, Hydroxychloroquine - Rheumatic Disease | Phase 2 | Recruiting | NYU Langone Health | 80 | 2025-12-12 | 2026-07-09 |
| A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease Firsekibart, Anakinra - Still's Disease, Adult-Onset | Active not recruiting | Ruijin Hospital | 20 | 2025-09-24 | 2026-10-16 | |
| IL1 Inhibition in FOP Anti-IL1 Therapy - Fibrodysplasia Ossificans Progressiva (FOP) | Recruiting | University of California, San Francisco | 11 | 2025-04-01 | 2026-08-06 | |
| Non Inferiority KawasakI Trial With Anakinra Anakinra, Intravenous Immunoglobulins, Human - Kawasaki Disease, Anakinra | Phase 4 | Not yet recruiting | Meyer Children's Hospital IRCCS | 38 | 2025-04-01 | 2024-11-21 |
| Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia Dexamethasone, Tocilizumab, Anakinra - Sepsis, Neuroinflammatory Response | Phase 4 | Unknown | Radboud University Medical Center | 52 | 2024-10-24 | 2025-04-04 |
| Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy ANAKINRA - FMF | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 50 | 2024-06-04 | 2025-06-25 |
| The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART) Anakinra - Heart Failure | Phase 1 | Completed | Virginia Commonwealth University | 4 | 2024-02-05 | 2026-09-04 |
| A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment ANAKINRA, Intravenous immunoglobulin - Kawasaki Disease | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 84 | 2023-10-20 | 2024-02-28 |
| Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β Anakinra, Placebo - Hyperinsulinemia, PreDiabetes | Phase 2 | Completed | University Hospital, Basel, Switzerland | 20 | 2023-06-15 | 2025-01-29 |
| Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children Anakinra, Prednisone - Pericarditis | Phase 3 | Unknown | Istituto Giannina Gaslini | 48 | 2023-06-01 | 2023-04-10 |
| Anakinra in Dengue With Hyperinflammation ( AnaDen ) Placebo, Anakinra - Dengue, Dengue With Warning Signs | Phase 2 | Active not recruiting | Oxford University Clinical Research Unit, Vietnam | 160 | 2023-01-02 | 2026-01-06 |
| A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF Anakinra - Cystic Fibrosis, 10011762 | Phase 2 | Terminated | Heidelberg University | 33 | 2022-12-01 | 2026-10-08 |
| The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis Anakinra, Sodium Chloride 9mg/ml Injection - Allergic Contact Dermatitis | Phase 3 | Completed | Herlev and Gentofte Hospital | 20 | 2022-10-11 | 2025-05-20 |
| A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD) Anakinra, Placebo - Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset | Phase 3 | Active not recruiting | Swedish Orphan Biovitrum | 15 | 2022-08-24 | 2025-03-05 |
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Inflammation (11) · COVID-19 (10) · Heart Failure (10) · Arthritis, Rheumatoid (7) · Arthritis, Juvenile (6) · Coronavirus Infections (5) · Cytokine Release Syndrome (5) · Mucocutaneous Lymph Node Syndrome (5) · Diabetes Mellitus, Type 1 (4) · Kidney Failure, Chronic (4) · Macrophage Activation Syndrome (4) · Pericarditis (4) · Pneumonia (4) · Asthma (3) · Familial Mediterranean Fever (3)
Virginia Commonwealth University (12) · Radboud University Medical Center (7) · Assistance Publique - Hôpitaux de Paris (6) · Swedish Orphan Biovitrum (6) · University Hospital, Basel, Switzerland (6) · Hellenic Institute for the Study of Sepsis (4) · Amgen (3) · Baylor Research Institute (3) · Duke University (3) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (3) · University of North Carolina, Chapel Hill (3) · Andrea Vambutas (2) · M.D. Anderson Cancer Center (2) · National Institute of Neurological Disorders and Stroke (NINDS) (2) · Ruijin Hospital (2)
United States (61) · France (13) · Italy (10) · Netherlands (10) · Switzerland (8) · Canada (6) · Greece (6) · Germany (5) · United Kingdom (5) · Sweden (4) · Australia (3) · Belgium (3) · Spain (3) · China (2) · Denmark (2)
Antonio Abbate, MD, PhD (3) · Benjamin Van Tassell, PharmD (3) · Michelle Hernandez, MD (3) · Andrea Vambutas, MD (2) · Benjamin W Van Tassell, PharmD (2) · Carlos Becerra, MD (2) · Nicole Blijlevens, MD PhD (2) · Walter W Chatham, MD (2) · A. Scott Paulson, MD (1) · Adrian Parry-Jones, PhD, MRCP (1) · Adriana H Tremoulet, MD (1) · Adriana Hung, MD (1) · Adriana Tremoulet, MD, MAS (1)
PMID 25133431, PMID 25482680, PMID 32275191, PMID 33394942, PMID 33935163, PMID 34473343, PMID 36529030, PMID 37489818, PMID 39531530, PMID 14987884, PMID 16003060, PMID 16899778, PMID 20597663, PMID 21173013, PMID 21194441, PMID 21310819, PMID 21518168, PMID 22253903, PMID 22273632, PMID 22294344, PMID 22438931, PMID 22822024, PMID 22859346, PMID 23453459, PMID 23562090, PMID 24183799, PMID 24467979, PMID 24782115, PMID 25121719, PMID 25223501, PMID 26320112, PMID 26438161, PMID 26444282, PMID 26579854, PMID 26584195, PMID 26903338, PMID 27080929, PMID 27143789, PMID 27418577, PMID 27825009, PMID 27856268, PMID 27860460, PMID 28118536, PMID 28265678, PMID 28324042, PMID 28335798, PMID 28475816, PMID 28918754, PMID 28962047, PMID 29284500
2023 (3), R01HL135235 (3), 2014 (2), 2015 (2), 1KL2RR031989-01 (1), 2005 (1), 2016 (1), 2017 (1), P30CA014089 (1), P30CA015083 (1), P30DK057516 (1), R01AG076360 (1), R01AR083628 (1), R21TR003103 (1), R33DC011827 (1)