Clinical trial NCT06040086: Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (MIRANDA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
COPD
tozorakimab
MEDI3506
exacerbations
ICS
LABA/LAMA
Biologic
Biologic Treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 1454
Sex: ALL
Minimum age (years): 40
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.


Eligibility criteria: Inclusion Criteria:

1. Participant must be ≥ 40 years of age 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 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
5. Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
6. Smoking history of ≥ 10 pack-years.
7. CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2

Exclusion 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. 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 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 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.

Primary outcomes:
measure: Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
timeFrame: Over 52 weeks
Secondary outcomes:
measure: Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
timeFrame: Over 52 weeks
measure: Change from baseline in SGRQ total score from in former smokers
timeFrame: Over 52 weeks
measure: Change from baseline in SGRQ total score from in the overall population of current and former smokers.
timeFrame: Over 52 weeks
measure: Annualized rate of severe COPD exacerbations in former smokers
timeFrame: Variable duration period up to study completion, approximately 3 years
measure: Annualized rate of severe COPD exacerbations in former or current smokers
timeFrame: Variable duration period up to study completion, approximately 3 years
measure: Change from baseline in E-RS:COPD total score in former smokers
timeFrame: Over 52 weeks
measure: Change from baseline in E-RS:COPD total score in former or current smokers
timeFrame: Over 52 weeks
measure: Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers
timeFrame: Week 52, over 52 weeks
measure: Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers
timeFrame: Week 52, over 52 weeks
measure: Time to first moderate to severe COPD exacerbation
timeFrame: Over 52 weeks
measure: Time to first severe COPD exacerbation
timeFrame: Variable duration period up to study completion, approximately 3 years
measure: Change from baseline in CAT total score
timeFrame: Week 52
measure: Proportion of participants achieving MCID in CAT score
timeFrame: Week 52
measure: Proportion of participants achieving MCID in SGRQ total score
timeFrame: Week 52
measure: Proportion of participants achieving MCID in E-RS:COPD total score
timeFrame: Week 52
measure: Annualized rate of healthcare resource utilization
timeFrame: Variable duration period up to study completion, approximately 3 years
measure: Change from baseline in rescue medication
timeFrame: Over 52 weeks
measure: Trough serum concentrations of tozorakimab
timeFrame: Over 52 weeks
measure: Presence of anti-drug antibodies
timeFrame: Over 52 weeks
measure: Time to death
timeFrame: Variable duration period up to study completion, approximately 3 years
Other outcomes:
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city: Leipzig
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city: München-Pasing
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city: München
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city: Solingen
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country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuantan
country: Malaysia
facility: Research Site
city: Seremban
country: Malaysia
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Den Bosch
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Roermond
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Santa Beatriz
country: Peru
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chrzanów
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Płock
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Badalona(Barcelona)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Mérida
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khlong Luang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Mueang
country: Thailand
facility: Research Site
city: Nakhon Ratchasima
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Tarasove Village
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zhytomyr
country: Ukraine
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Macclesfield
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
city: Ha Noi
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh
country: Vietnam
facility: Research Site
Study officials:
References: