2870 Participants Needed

Tozorakimab for Viral Pneumonia

(TILIA Trial)

Recruiting at 296 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves adding tozorakimab to the standard of care (SoC), it's likely you can continue your current treatments. Please consult with the trial coordinators for specific guidance.

What data supports the idea that Tozorakimab for Viral Pneumonia is an effective drug?

The available research does not provide any data on Tozorakimab for Viral Pneumonia. Instead, the research focuses on a different drug, Tocilizumab, which is used for treating rheumatoid arthritis and other conditions. There is no information here about Tozorakimab's effectiveness for Viral Pneumonia or any other condition.12345

What safety data exists for Tozorakimab (MEDI-3506) for viral pneumonia?

The provided research does not contain safety data for Tozorakimab (MEDI-3506) or its use in viral pneumonia. The studies focus on other interleukin-6 inhibitors like tocilizumab and olokizumab, primarily in the context of rheumatoid arthritis.16789

Is the drug Tozorakimab a promising treatment for viral pneumonia?

The information provided focuses on tocilizumab, a drug similar to Tozorakimab, which has shown promise in treating severe COVID-19 by targeting the immune system's response. This suggests that Tozorakimab could also be a promising treatment for viral pneumonia.110111213

What is the purpose of this trial?

This trial is testing tozorakimab, a medication that may help people with severe viral lung infections who need extra oxygen. The goal is to see if it can prevent death or the need for advanced breathing support. Tozorakimab works by reducing harmful inflammation in the lungs.

Eligibility Criteria

This trial is for adults over 18 hospitalized with a viral lung infection needing extra oxygen but not on mechanical ventilation or ECMO. They must have low blood oxygen levels and signs of the infection on chest scans, use extra muscles to breathe, or have a high respiratory rate.

Inclusion Criteria

I have low oxygen levels and signs of a lung infection or difficulty breathing.
I need extra oxygen to help me breathe.
I am in the hospital due to a lung infection caused by a virus.

Exclusion Criteria

My low oxygen levels are due to a non-infectious lung injury or an external cause.
You are currently using a ventilator or an ECMO machine at the time of randomization.
I do not have a fungal, parasitic lung infection, lung abscess, or severe lung infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of tozorakimab or placebo as an add-on to Standard of Care (SoC) for viral lung infection requiring supplemental oxygen

Single dose
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including ICU admission, ventilator use, and survival outcomes

60 days

Treatment Details

Interventions

  • Placebo
  • Tozorakimab
Trial Overview The study tests Tozorakimab's effectiveness when added to standard care in preventing death or the need for intensive breathing support (IMV/ECMO) in patients with severe viral lung infections requiring supplemental oxygen.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TozorakimabExperimental Treatment1 Intervention
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 1 (n=approximately 1435) will receive a single dose of tozorakimab.
Group II: PlaceboPlacebo Group1 Intervention
Approximately 2870 participants will be randomized in a 1:1 ratio. Arm 2 (n=approximately 1435) will receive matching placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

Tocilizumab, when given at the approved dose of 8 mg/kg every 4 weeks in combination with methotrexate, significantly improves rheumatoid arthritis symptoms, with a higher likelihood of achieving important clinical outcomes compared to placebo, including a 38.8% response rate versus 9.6% for placebo.
While tocilizumab treatment was associated with a higher incidence of any adverse events and increased cholesterol levels, it did not lead to a significant increase in serious adverse effects or withdrawals due to adverse events, indicating a favorable safety profile overall.
Tocilizumab for rheumatoid arthritis: a Cochrane systematic review.Singh, JA., Beg, S., Lopez-Olivo, MA.[2018]
In a meta-analysis of 19 randomized controlled trials involving 7,835 patients with rheumatoid arthritis, abatacept was found to significantly increase the likelihood of achieving an ACR70 response compared to tocilizumab, with a relative risk of 2.217.
Rituximab did not show a significant difference in achieving ACR70 response compared to abatacept, indicating that while all three treatments are options for refractory RA, abatacept may offer superior efficacy over tocilizumab under similar study conditions.
Compared efficacy of rituximab, abatacept, and tocilizumab in patients with rheumatoid arthritis refractory to methotrexate or TNF inhibitors agents: a systematic review and network meta-analysis.Pugliesi, A., de Oliveira, AB., Oliveira, AB., et al.[2023]
In a study involving 1681 patients with rheumatoid arthritis who had inadequate responses to previous treatments, tocilizumab showed rapid and sustained efficacy, with significant improvements in disease activity scores over 24 weeks.
The treatment was generally safe, with a low discontinuation rate of 5.1% due to adverse events, although patients who had recently used TNF inhibitors experienced a higher rate of adverse events compared to those who had never used them.
Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice.Bykerk, VP., Ostör, AJ., Alvaro-Gracia, J., et al.[2021]

References

Tocilizumab for rheumatoid arthritis: a Cochrane systematic review. [2018]
Compared efficacy of rituximab, abatacept, and tocilizumab in patients with rheumatoid arthritis refractory to methotrexate or TNF inhibitors agents: a systematic review and network meta-analysis. [2023]
Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. [2021]
A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. [2016]
A Review of Recent Advances Using Tocilizumab in the Treatment of Rheumatic Diseases. [2023]
Tocilizumab in the treatment of patients with rheumatoid arthritis in real clinical practice: results of an Italian observational study. [2018]
Tocilizumab: an interleukin-6 receptor inhibitor for the treatment of rheumatoid arthritis. [2016]
Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. [2022]
Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. [2023]
A single-center experience in use of tocilizumab in COVID-19 pneumonia in India. [2023]
Single dose tocilizumab for COVID-19 associated cytokine storm syndrome: Less is more. [2023]
Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. [2022]
The Use of Tocilizumab in Patients with COVID-19: A Systematic Review, Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Studies. [2021]
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