Clinical trial NCT06878261: A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
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: 2025-03-14
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: Tempe
country: United States
facility: Research Site
state: Arizona
city: Redding
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Fleming Island
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Leesburg
country: United States
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state: Florida
city: Margate
country: United States
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state: Florida
city: Miami Lakes
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Ocala
country: United States
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state: Florida
city: Palmetto Bay
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Adairsville
country: United States
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state: Georgia
city: Fayetteville
country: United States
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state: Georgia
city: Fort Eisenhower
country: United States
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state: Georgia
city: Savannah
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state: Georgia
city: Evansville
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Indianapolis
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city: Kansas City
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state: Kansas
city: Bowling Green
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state: Kentucky
city: Owensboro
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state: Kentucky
city: Baltimore
country: United States
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state: Maryland
city: Potomac
country: United States
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state: Maryland
city: Ann Arbor
country: United States
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state: Michigan
city: Minneapolis
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city: Hannibal
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city: Charlotte
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state: North Carolina
city: Fayetteville
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state: North Carolina
city: Oklahoma City
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state: Oklahoma
city: Tulsa
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city: Grants Pass
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state: Oregon
city: Anderson
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state: South Carolina
city: Columbia
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city: Gaffney
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city: Spartanburg
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city: Union
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Knoxville
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state: Tennessee
city: Boerne
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state: Texas
city: El Paso
country: United States
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state: Texas
city: Houston
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state: Texas
city: Lewisville
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city: McKinney
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city: Mesquite
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state: Texas
city: Missouri City
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state: Vermont
city: Williamsburg
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state: Virginia
city: Everett
country: United States
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state: Washington
city: Alberdi
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Florencio Varela
country: Argentina
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city: Florida
country: Argentina
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city: La Plata
country: Argentina
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city: La Plata
country: Argentina
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city: Mar del Plata
country: Argentina
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city: Mendoza
country: Argentina
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city: Quilmes
country: Argentina
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city: San Fernando
country: Argentina
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city: Coffs Harbour
country: Australia
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city: Frankston
country: Australia
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city: Garran
country: Australia
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city: Nedlands
country: Australia
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city: Spearwood
country: Australia
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city: Wollongong
country: Australia
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city: Woodville South
country: Australia
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city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Jette
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Dupnitsa
country: Bulgaria
facility: Research Site
city: Haskovo
country: Bulgaria
facility: Research Site
city: Lovech
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tanovo
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vidin
country: Bulgaria
facility: Research Site
city: Yambol
country: Bulgaria
facility: Research Site
city: Armenia
country: Colombia
facility: Research Site
city: Barranquilla
country: Colombia
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city: Bogotá
country: Colombia
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city: Cali
country: Colombia
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city: Ibague
country: Colombia
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city: Manizales
country: Colombia
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city: Medellin
country: Colombia
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city: Medellín
country: Colombia
facility: Research Site
city: Aalborg
country: Denmark
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city: Hvidovre
country: Denmark
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city: Næstved
country: Denmark
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city: Odense C
country: Denmark
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city: Vejle
country: Denmark
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city: Brest Cedex 2
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
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city: Marseille
country: France
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city: Montpellier Cedex 5
country: France
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city: Paris Cedex 18
country: France
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country: France
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city: Pessac
country: France
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city: Saint Herblain
country: France
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city: Athens
country: Greece
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city: Athens
country: Greece
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city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
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city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
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city: Hong Kong
country: Hong Kong
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Edelény
country: Hungary
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city: Gödöllő
country: Hungary
facility: Research Site
city: Hatvan
country: Hungary
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city: Mosonmagyaróvár
country: Hungary
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city: Nyíregyháza-Sóstóhegy
country: Hungary
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city: Törökbálint
country: Hungary
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city: Ashkelon
country: Israel
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city: Haifa
country: Israel
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city: Jerusalem
country: Israel
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city: Jerusalem
country: Israel
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city: Kfar Saba
country: Israel
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city: Ramat Gan
country: Israel
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city: Rehovot
country: Israel
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city: Tel Aviv
country: Israel
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city: Akashi-shi
country: Japan
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city: Chikushino-shi
country: Japan
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city: Chiyoda-ku
country: Japan
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city: Fukui-shi
country: Japan
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city: Fukuoka-shi
country: Japan
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city: Fukuoka-shi
country: Japan
facility: Research Site
city: Gifu-shi
country: Japan
facility: Research Site
city: Ishinomaki
country: Japan
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city: Kasuga-shi
country: Japan
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city: Kitakyushu-shi
country: Japan
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city: Kiyose-shi
country: Japan
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city: Kiyose-shi
country: Japan
facility: Research Site
city: Kobe-shi
country: Japan
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city: Komatsu-shi
country: Japan
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city: Kure-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
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city: Meguro-ku
country: Japan
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city: Minato-ku
country: Japan
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city: Minato-ku
country: Japan
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city: Miyazaki-shi
country: Japan
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city: Nagaoka-shi
country: Japan
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city: Nagasaki-shi
country: Japan
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city: Nagoya-shi
country: Japan
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city: Nagoya-shi
country: Japan
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city: Nerima-ku
country: Japan
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city: Ohta-ku
country: Japan
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city: Okayama-shi
country: Japan
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city: Okayama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
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city: Shinjuku-ku
country: Japan
facility: Research Site
city: Shiogama City
country: Japan
facility: Research Site
city: Takamatsu-shi
country: Japan
facility: Research Site
city: Takatsuiki-shi
country: Japan
facility: Research Site
city: Tanabe-shi
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
city: Ube
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
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city: Yokohama-shi
country: Japan
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Maastricht
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: Auckland
country: New Zealand
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Hamilton West
country: New Zealand
facility: Research Site
city: Tauranga
country: New Zealand
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city: Lima
country: Peru
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city: Lima
country: Peru
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: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Somerset West
country: South Africa
facility: Research Site
city: Tygervalley
country: South Africa
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Bang Kra So
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Hatyai
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: Rayong
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Da Nang
country: Vietnam
facility: Research Site
city: Hai Phong
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: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
affiliation: University of Michigan Health, Pulmonary & Critical Care Medicine,
name: MeiLan Han, MD
role: PRINCIPAL_INVESTIGATOR
References: