Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations

JRCT ID: jRCT2041230113

Registered date:03/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COPD
• Date of first enrollment: 17/01/2024
• Target sample size: 55
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Brazill,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Thailand,Japan,United Kingdom,Japan,US,Japan,Vietnam,Japan,Hong Kong,Japan,Peru,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Intervention name: Tozorakimab
Description: Administered subcutaneously tozorakimab o throughout the study.

Intervention Name: Placebo
Description: Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.

Outcome(s)

• Primary Outcome: Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers. (Time Frame: over 52 weeks.)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participant must be 40 years of age or more and capable of giving signed informed consent.

2. Documented diagnosis of COPD for at least one year prior to enrolment.Documented diagnosis of COPD for at least one year prior to enrolment.

3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predictedPost BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.

4. Documented history of 2 or more moderate or 1 or more severe COPD exacerbations within 12 months prior to enrolment.

5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.

6. Smoking history of 10 pack-years or more.

7. CAT total score 10 or more, and each of the phlegm (sputum) and cough items 2 or more.

Exclude criteria

1. Clinically important pulmonary disease other than COPD.

2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly cRadiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.

3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and reCurrent diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.

4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrAny unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.

5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.

6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical conActive significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.

7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.

8. Significant COVID-19 illness within the 6 months prior to enrolment.

9. Unstable cardiovascular disorder.

10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.

11. History of active severe inflammatory bowel disease or colitis within one year prior to eHistory of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.

12. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.

13. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)

14. Evidence of active liver disease, including jaundice during screening.

15. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.

16. Participants who have evidence of active TB.

17. History of partial or total lung resection.

18. Scheduled major surgical procedure during the course of the study.

19. Participants that have previously received tozorakimab.

20. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06040086