Clinical trial NCT06883305: A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Moderate COPD
Severe COPD
Very Severe COPD
chronic obstructive pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2025-03-19
Enrollment: 990
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised in a ratio of 1:1:1 to receive Dose 1 of tezepelumab, Dose 2 of tezepelumab or matching placebo.
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed description: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. ≥40 to ≤80 years old
2. COPD diagnosis ≥1 year,
3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids
6. EOS ≥ 150 cells/μL during screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years

Exclusion Criteria:

1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
2. Asthma, incl. pediatric, or ACOS
3. Any unstable disorder that can impact participants safety or study outcomes
4. Tuberculosis requiring treatment within 12 months prior V2
5. Malignancies current or past

   Concomitant therapies:
   * Macrolides (less than 6 months)
   * Systemic immuno-suppressive, -modulating medications
6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Primary outcomes:
measure: Annualised rate of moderate or severe COPD exacerbations
timeFrame: Baseline up to 76 weeks
Secondary outcomes:
measure: Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
timeFrame: From baseline to Week 52
measure: Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score
timeFrame: From baseline over 52 weeks
measure: Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL.
timeFrame: Baseline up to 76 weeks
measure: Annualised rate of severe COPD exacerbations
timeFrame: Baseline up to 76 weeks
measure: Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
timeFrame: From baseline over 52 weeks
measure: Change from baseline in the COPD assessment Test (CAT) total score
timeFrame: From baseline over 52 weeks
measure: Clinical meaningful improvement in COPD Assessment Test (CAT) total score
timeFrame: From baseline over 52 weeks
measure: Time to first moderate to severe COPD exacerbation
timeFrame: Baseline up to 76 weeks
measure: Time to first severe COPD exacerbation
timeFrame: Baseline up to 76 weeks
measure: Change from baseline in post-BD FEV1
timeFrame: From baseline to Week 52
measure: Pharmacokinetics (PK): Serum trough concentrations
timeFrame: Baseline, Week 24, Week 36, Week 52
measure: Immunogenicity of anti-drug antibodies (ADA)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Foley
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Sheffield
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Newport Beach
country: United States
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state: California
city: Cutler Bay
country: United States
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state: Florida
city: DeBary
country: United States
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state: Florida
city: Homestead
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city: Miami
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city: Orlando
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city: Rincon
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city: Evanston
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state: Illinois
city: Winfield
country: United States
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state: Illinois
city: Columbia
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state: Maryland
city: North Dartmouth
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state: Massachusetts
city: Farmington Hills
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state: Michigan
city: Saint Cloud
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city: Papillion
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city: Las Vegas
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state: Nevada
city: Sewell
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state: New Jersey
city: Toms River
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city: Buffalo
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city: Buffalo
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city: Horseheads
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state: North Carolina
city: New Bern
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city: Dublin
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city: Oklahoma City
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city: Rock Hill
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city: Johnson City
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city: Houston
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state: Texas
city: Kerrville
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city: Mansfield
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state: Wisconsin
city: Milwaukee
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state: Wisconsin
city: Bragança Paulista
country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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city: Curitiba
country: Brazil
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country: Brazil
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country: Brazil
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city: Salvador
country: Brazil
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city: Sao Jose Do Rio Preto
country: Brazil
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country: Brazil
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city: Calgary
country: Canada
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state: Alberta
city: Vancouver
country: Canada
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state: British Columbia
city: Ajax
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city: Burlington
country: Canada
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city: Scarborough
country: Canada
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city: Toronto
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city: Windsor
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city: Montreal
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city: St Charles Borromee
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city: Saskatoon
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state: Saskatchewan
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city: Concepción
country: Chile
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city: Curico
country: Chile
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city: Quillota
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Talca
country: Chile
facility: Research Site
city: Anyang
country: China
facility: Research Site
city: Beijing
country: China
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city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
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city: Changsha
country: China
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city: Changsha
country: China
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city: Chengdu
country: China
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city: Chengdu
country: China
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city: Chongqing
country: China
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city: Chongqing
country: China
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city: Fuzhou
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Nan Chong
country: China
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country: China
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city: Nanjing
country: China
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country: China
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country: China
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country: China
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city: Pingxiang
country: China
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city: Qingdao
country: China
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city: Qingyuan
country: China
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city: Sanya
country: China
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city: Shanghai
country: China
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country: China
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country: China
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city: Shantou
country: China
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city: Shenyang
country: China
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city: Shenzhen
country: China
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city: Shijiazhuang
country: China
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city: Suining Shi
country: China
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city: Taiyuan
country: China
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country: China
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city: Taizhou
country: China
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country: China
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country: China
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country: China
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country: China
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city: Xinxiang
country: China
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city: Xuzhou
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Zhangzhou
country: China
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city: Brandys nad Labem
country: Czechia
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city: Brno
country: Czechia
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city: Jindrichuv Hradec
country: Czechia
facility: Research Site
city: Lovosice
country: Czechia
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city: Ostrava
country: Czechia
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city: Plzen
country: Czechia
facility: Research Site
city: Praha 16
country: Czechia
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city: Praha 1
country: Czechia
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city: Teplice
country: Czechia
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city: Varnsdorf
country: Czechia
facility: Research Site
city: København NV
country: Denmark
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city: Bendorf
country: Germany
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city: Berlin
country: Germany
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city: Haltern Am See
country: Germany
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city: Hannover
country: Germany
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city: Immenhausen
country: Germany
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city: Lübeck
country: Germany
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city: Marburg
country: Germany
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city: Rosenheim
country: Germany
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city: Stuttgart
country: Germany
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city: Wiesbaden
country: Germany
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city: Ahmedabad
country: India
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city: Ahmedabad
country: India
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city: Belagavi
country: India
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city: Coimbatore
country: India
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city: Dehradun
country: India
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city: Delhi
country: India
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city: Faridabad
country: India
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city: Gurgaon
country: India
facility: Research Site
city: Kochi
country: India
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city: Kolkata
country: India
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city: Lucknow
country: India
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city: Madurai
country: India
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city: Mysuru
country: India
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city: Nagpur
country: India
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city: Pune
country: India
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city: Vadodara
country: India
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city: Firenze
country: Italy
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city: Milan
country: Italy
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city: Montebelluna
country: Italy
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city: Napoli
country: Italy
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city: Pavia
country: Italy
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city: Roma
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Telese Terme
country: Italy
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city: Tradate
country: Italy
facility: Research Site
city: Anyang-si
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Iksan-si
country: Korea, Republic of
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city: Jeonju
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
city: Wonju-si
country: Korea, Republic of
facility: Research Site
city: Alor Setar
country: Malaysia
facility: Research Site
city: Kajang
country: Malaysia
facility: Research Site
city: Kota Kinabalu
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuala Terengganu
country: Malaysia
facility: Research Site
city: Kuantan
country: Malaysia
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Benito Juarez
country: Mexico
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city: Chihuahua
country: Mexico
facility: Research Site
city: Cuauhtémoc
country: Mexico
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city: Cuernavaca
country: Mexico
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city: Guadalajara
country: Mexico
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city: Merida
country: Mexico
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city: Monterrey
country: Mexico
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city: Monterrey
country: Mexico
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city: Monterrey
country: Mexico
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city: Morelia
country: Mexico
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city: Oaxaca
country: Mexico
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city: San Juan del Rio
country: Mexico
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city: Tijuna
country: Mexico
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city: Veracruz
country: Mexico
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city: Zapopan
country: Mexico
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city: Zapopan
country: Mexico
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Iloilo
country: Philippines
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city: Las Pinas
country: Philippines
facility: Research Site
city: Manadaluyong City
country: Philippines
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city: Manila
country: Philippines
facility: Research Site
city: Marilao
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Tondo
country: Philippines
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bydgoszcz
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: Karczew
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostróda
country: Poland
facility: Research Site
city: Piaseczno
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Płock
country: Poland
facility: Research Site
city: Humenne
country: Slovakia
facility: Research Site
city: Košice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Barakaldo
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
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city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Halifax
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Tyne And Wear
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: