Table 1.
Ongoing rIL-1RA clinical trials.
| Study title | Phase | Primary outcome measures | Anakinra dose |
|---|---|---|---|
| Anakinra combined with chemotherapy and dendritic cell vaccine to treat breast cancer | 1/2 | Safety of DC vaccine combined with chemotherapy, and DC vaccine combined with chemotherapy and anakinra | 100 mg/day subcutaneous |
| Infants and children with coronary artery abnormalities in acute Kawasaki disease | 1/2 | Safety of a 6-week course of anakinra | 2 mg/kg/day 4 mg/kg/day |
| Adult patients with colchicine-resistant familial Mediterranean fever | 3 | Number of patients with less than a mean of one FMF attack per month | 100 mg/day subcutaneous |
| Safety and blood immune cell study of anakinra in metastatic breast cancer patients | 1 | Safety – adverse events in participants | 100 mg/day subcutaneous |
| Anakinra or denosumab and everolimus in advanced cancer | 1 | Maximum tolerated dose (MTD) | 100 mg/day subcutaneous |
| Efficacy study of anakinra, pentoxifylline, and zinc compared to methylprednisolone in severe acute alcoholic hepatitis | 2/3 | Death|MELD score | 100 mg/day subcutaneous |
| Safety and tolerability of anakinra in combination with riluzol in amyotrophic lateral sclerosis | 2 | Number and severity of adverse events, pathological laboratory parameters | 100 mg/day subcutaneous |
| IL-1 blockade in acute myocardial infarction (VCU-ART3) | 2/3 | Acute response (CRP levels) | 100 mg/day subcutaneous |
| Study evaluating the influence of LV5FU2 bevacizumab plus anakinra association on metastatic colorectal cancer | 2 | Response rate after 2 months in patients with colorectal cancer with liver metastases treated with anakinra and LV5FU2/bevacizumab | 100 mg/day subcutaneous |
| Evaluation of the safety of anakinra plus standard chemotherapy | 1 | The number of participants with serious adverse events and adverse events | 100 mg/day subcutaneous |
| IL-1 blockade in acute heart failure (anakinra ADHF) | 2/3 | C reactive protein | 200 mg/day for 3 days (high dose) |
| 100 mg/day (standard dose) | |||
| Interleukin-1 blockade in recently decompensated heart failure | 2/3 | Placebo-corrected interval changes in peak VO2 and VE/VCO2 slope | 100 mg/day subcutaneous |
| Inflammatory pustular skin diseases | 2 | Obtain an estimate of the response rate to treatment | 100–300 mg/day subcutaneous |
| Effect of anakinra on insulin sensitivity in type 1 diabetes mellitus | 2 | Insulin sensitivity as determined by euglycemic hyperinsulinemic clamp | 100 mg/day subcutaneous |
| Gene expression profiling in PBMCs as a tool for prediction of anakinra responsiveness in rheumatoid arthritis | 4 | Observational | 100 mg/day subcutaneous |
| Role of interleukin-1 in postprandial fatigue | 1 | Postprandial fatigue | 100 mg subcutaneous |
| Immunomodulation, IL-1 inhibition, and postoperative incisional pain | N/Aa | Concentration levels of inflammatory mediators (IL-1, IL-6, IL-8, and TNF-α) present in human wounds following surgery with and without the use of anakinra | N/Aa |
| Cytokine inhibition in chronic fatigue syndrome patients | 2/3 | CIS (checklist individual strength, compared to baseline) | 100 mg/day subcutaneous |
| A dose-block randomized, placebo controlled (double-blind), active controlled(open-label), dose-escalation study | 1 | Tolerability, pharmacokinetics of HL2351, Immunogenicity of HL2351, Tolerability, pharmacokinetics, and pharmacodynamics of HL2351 in comparison with kineret (anakinra), IL-6 inhibition assay | 100 mg/day subcutaneous |
| Anti-IL-1 treatment in children DKA at diagnosis of type 1 diabetes | 2 | Number of adverse events | 2 mg/kg bolus followed by 2 mg/kg/h infusion |
| Interleukin-1 blockade in HF with preserved EF | 2 | Aerobic exercise capacity, ventilatory efficiency | 100 mg/day subcutaneous |
aData not available.