A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations

JRCT ID: jRCT2031210563

Registered date:19/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COPD
• Date of first enrollment: 05/01/2022
• Target sample size: 44
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,Hungary,Japan,India,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Turkey,Japan,US,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

Drug: Tozorakimab
Administered subcutaneously Tozorakimab Dose 1 and placebo through Week 52.
Drug: Tozorakimab
Administered subcutaneously Tozorakimab. Dose 2 through Week 52.
Drug: Placebo
Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

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.

3. Post 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 contributing to the participant's respiratory symptoms.

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 resolved before the age of 18.

4. Any 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 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 known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.

12. History of positive test or treatment for hepatitis B or hepatitis C.

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

14. 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.

15. Participants who have evidence of active TB.

16. Participants that have previously received MEDI3506.

17. 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.

18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05166889