Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003107-15-SK

Enrollment

2902

Registered

2022-11-29

Start date

2023-04-01

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe viral lung infections MedDRA version: 21.1 Level: PT Classification code 10001053 Term: Acute respiratory failure System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: tozorakimab Product Code: MEDI3506 Pharmaceutical Form: Solution for injection INN or Proposed INN: tozorakimab CAS Number: 2376858-66-9 Current Sponsor code: MEDI3506 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult participants = 18 years old at the time of signing the informed consent form. 2. Patients hospitalised with viral lung infection. 3. Hypoxaemia requiring treatment with supplemental O2. Hypoxaemia is defined as: SpO2 = 90% OR SpO2 = 92% AND one or both of the following: Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement. Use of accessory muscles of respiration or RR > 22. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1176 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1176

Exclusion criteria

Exclusion criteria: 1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant's condition. 2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology. 3. Ongoing IMV/ECMO at randomisation. 4. The following malignancies: - Solid tumours with metastases (Stage IV). - Lymphoma/leukaemia not in complete remission. - Malignancies treated with chemotherapy and/or immunomodulatory drugs within the past 2 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28;Secondary Objective: 1. To evaluate the effect of tozorakimab versus placebo as add-on to standard of care on: a) all-cause mortality by Day 60 b) ICU stay c) duration of oxygen supplementation d) prolonging time to death or IMV/ECMO e) prolonging time to death f) ventilator use g) ICU admissions h) duration of hospitalisation i) clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale by Day 60. 2. To evaluate the pharmacokinetics and immunogenicity of tozorakimab in participants with viral lung infection requiring supplemental oxygen. 3. To evaluate the use of baseline serum biomarker levels to predict treatment response with tozorakimab versus placebo as add on to standard of care. 4. To assess the safety and tolerability of tozorakimab versus placebo as add-on to standard of care. 5. To evaluate the effect of tozorakimab as add on to SoC on a series of HRU endpoints.;Primary end point(s): Proportion of participants who die or progress to IMV/ECMO;Timepoint(s) of evaluation of this end point: By Day 28	—

Measure

Time frame

Main Objective: To evaluate the effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 28;Secondary Objective: 1. To evaluate the effect of tozorakimab versus placebo as add-on to standard of care on: a) all-cause mortality by Day 60 b) ICU stay c) duration of oxygen supplementation d) prolonging time to death or IMV/ECMO e) prolonging time to death f) ventilator use g) ICU admissions h) duration of hospitalisation i) clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale by Day 60. 2. To evaluate the pharmacokinetics and immunogenicity of tozorakimab in participants with viral lung infection requiring supplemental oxygen. 3. To evaluate the use of baseline serum biomarker levels to predict treatment response with tozorakimab versus placebo as add on to standard of care. 4. To assess the safety and tolerability of tozorakimab versus placebo as add-on to standard of care. 5. To evaluate the effect of tozorakimab as add on to SoC on a series of HRU endpoints.;Primary end point(s): Proportion of participants who die or progress to IMV/ECMO;Timepoint(s) of evaluation of this end point: By Day 28

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of participants who die 2. Number of days alive and outside of ICU 3. Number of days alive and free of supplemental oxygen 4. Time to death or progression to IMV/ECMO 5. Proportion of participants who die or progress to IMV/ECMO 6. Time to death (all cause) 7. Proportion of participants who die 8. Number of days alive and free of IMV/ECMO 9. Number of days alive and ventilator free 10. Proportion of participants with ICU admission or death 11. Proportion of participants alive and discharged 12. Time to discharge 13. Time to being off supplemental oxygen 14. WHO CPS score rank-based comparison 15. Incidence of anti-drug antibodies 16. Baseline serum biomarker levels relative to primary endpoint;Timepoint(s) of evaluation of this end point: 1. By Day 60 2. Over 28 day period 3. Over 28 day period 4. NA 5. By Day 60 6. NA 7. By Day 28 8. Over 28 day and 60 day period 9. Over 28 day and 60 day period 10. By Day 28 and Day 60 11. By Day 28 and Day 60 12. NA 13. NA 14. NA 15. NA 16. NA	—

Measure

Time frame

Secondary end point(s): 1. Proportion of participants who die 2. Number of days alive and outside of ICU 3. Number of days alive and free of supplemental oxygen 4. Time to death or progression to IMV/ECMO 5. Proportion of participants who die or progress to IMV/ECMO 6. Time to death (all cause) 7. Proportion of participants who die 8. Number of days alive and free of IMV/ECMO 9. Number of days alive and ventilator free 10. Proportion of participants with ICU admission or death 11. Proportion of participants alive and discharged 12. Time to discharge 13. Time to being off supplemental oxygen 14. WHO CPS score rank-based comparison 15. Incidence of anti-drug antibodies 16. Baseline serum biomarker levels relative to primary endpoint;Timepoint(s) of evaluation of this end point: 1. By Day 60 2. Over 28 day period 3. Over 28 day period 4. NA 5. By Day 60 6. NA 7. By Day 28 8. Over 28 day and 60 day period 9. Over 28 day and 60 day period 10. By Day 28 and Day 60 11. By Day 28 and Day 60 12. NA 13. NA 14. NA 15. NA 16. NA

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States, Viet Nam

Contacts

Public ContactClinical Study Information Center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026