A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

NCT06883305 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D5241C00006
• Study Type: interventional
• Target: 990
• Locations: 18 countries
• Sites: 301

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)

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Moderate COPD; Severe COPD; Very Severe COPD; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Annualised rate of moderate or severe COPD exacerbations

  The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

  Baseline up to 76 weeks

Secondary Outcomes (13)

• Change from baseline in post-BD FEV1

  From baseline to Week 52

• Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

  From baseline to Week 52

• Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score

  From baseline over 52 weeks

• Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.

  Baseline up to 76 weeks

• Annualised rate of severe COPD exacerbations

  Baseline up to 76 weeks

Study Arms (3)

Dose 1 of Tezepelumab

EXPERIMENTAL

Tezepelumab, SC, Q4W

Biological: Tezepelumab

Dose 2 of Tezepelumab

EXPERIMENTAL

Tezepelumab, SC, Q4W

Biological: Tezepelumab

Matching Placebo

PLACEBO COMPARATOR

Matching placebo, SC, Q4W

Other: Placebo

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Dose 1 of Tezepelumab; Dose 2 of Tezepelumab

Placebo OTHER

Placebo subcutaneous injection

Matching Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥40 to ≤80 years old
• COPD diagnosis ≥1 year,
• Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
• Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
• ≥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. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
• EOS ≥ 150 cells/μL during screening
• CAT ≥15 at screening
• Former or current smokers ≥10 pack-years

You may not qualify if:

• Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
• Asthma, incl. pediatric, or ACOS
• Any unstable disorder that can impact participants safety or study outcomes
• Tuberculosis requiring treatment within 12 months prior V2
• Malignancies current or past
• Concomitant therapies:
• Macrolides (less than 6 months)
• Systemic immuno-suppressive, -modulating medications
• LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (301)

Research Site

Foley, Alabama, 36535, United States

RECRUITING

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Mobile, Alabama, 36609, United States

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Sheffield, Alabama, 35660, United States

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Phoenix, Arizona, 85012, United States

NOT YET RECRUITING

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Phoenix, Arizona, 85027, United States

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Tucson, Arizona, 85704, United States

WITHDRAWN

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Garden Grove, California, 92844, United States

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Newport Beach, California, 92663, United States

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Torrance, California, 90502, United States

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Clearwater, Florida, 33765, United States

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Cutler Bay, Florida, 33157, United States

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Cutler Bay, Florida, 33189, United States

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DeBary, Florida, 32713, United States

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Gainesville, Florida, 32608, United States

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Homestead, Florida, 33032, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33175, United States

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Orlando, Florida, 32807, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33607, United States

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Atlanta, Georgia, 30344, United States

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Lithonia, Georgia, 30038, United States

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Rincon, Georgia, 31326, United States

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Chicago, Illinois, 60611, United States

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Palos Hills, Illinois, 60465, United States

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Winfield, Illinois, 60190, United States

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Munster, Indiana, 46321, United States

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Baltimore, Maryland, 21201, United States

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Columbia, Maryland, 21045, United States

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North Dartmouth, Massachusetts, 02747, United States

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Farmington Hills, Michigan, 48336, United States

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Saint Cloud, Minnesota, 56303, United States

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St Louis, Missouri, 63103, United States

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Missoula, Montana, 59808, United States

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Papillion, Nebraska, 68046, United States

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Las Vegas, Nevada, 89106, United States

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Sewell, New Jersey, 08080, United States

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Toms River, New Jersey, 08755, United States

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Buffalo, New York, 14203, United States

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Buffalo, New York, 14215, United States

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Cortland, New York, 13045, United States

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Horseheads, New York, 14845, United States

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High Point, North Carolina, 27260, United States

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Kings Mountain, North Carolina, 28086, United States

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New Bern, North Carolina, 28562, United States

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Wilmington, North Carolina, 28412, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73120, United States

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DuBois, Pennsylvania, 15801, United States

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Philadelphia, Pennsylvania, 19140, United States

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Rock Hill, South Carolina, 29732, United States

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Franklin, Tennessee, 37067, United States

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Johnson City, Tennessee, 37604, United States

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Dallas, Texas, 75254, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77084, United States

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Houston, Texas, 77090, United States

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Humble, Texas, 77338, United States

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Kerrville, Texas, 78028, United States

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Mansfield, Texas, 76063, United States

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Clearfield, Utah, 84015, United States

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Morgantown, West Virginia, 26501, United States

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Cudahy, Wisconsin, 53110, United States

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Milwaukee, Wisconsin, 53295, United States

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Bragança Paulista, 12916-542, Brazil

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Brasília, 70200-730, Brazil

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Campinas, 13060-080, Brazil

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Chapecó, 89812-210, Brazil

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Curitiba, 80030-110, Brazil

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Jaú, 17201-130, Brazil

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Mossoró, 59603-020, Brazil

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Porto Alegre, 90035-903, Brazil

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Porto Alegre, 90480-000, Brazil

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Porto Alegre, 90560-003, Brazil

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Porto Alegre, 9061-000, Brazil

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Porto Alegre, 91350-200, Brazil

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Salvador, 40050-410, Brazil

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São José do Rio Preto, 15090-000, Brazil

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Vitória, 29062-110, Brazil

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Calgary, Alberta, T3R 1W7, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Scarborough Village, Ontario, M1P 2V5, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Winchester, Ontario, K0C 2K0, Canada

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Windsor, Ontario, N8X-5A6, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G1V 4G5, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Saint-Laurent, Quebec, H4R3C8, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Concepción, 4070094, Chile

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Curicó, 3341643, Chile

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Quillota, 2260000, Chile

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Santiago, 7500010, Chile

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Santiago, 7500657, Chile

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Santiago, 7501126, Chile

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Santiago, 7750495, Chile

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Santiago, 8380453, Chile

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Talca, 3481349, Chile

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Anyang, 455099, China

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Beijing, 100020, China

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Beijing, 100191, China

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Changchun, 130021, China

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Changsha, 410008, China

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Changsha, 410015, China

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Changsha, 430033, China

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Chengdu, 610072, China

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Chengdu, 611130, China

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Chongqing, 400042, China

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Chongqing, 401320, China

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Fuzhou, 350031, China

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Guangzhou, 510000, China

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Guangzhou, 510150, China

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Guangzhou, 510163, China

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Guangzhou, 510515, China

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Haikou, 570311, China

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Hangzhou, 310005, China

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Hefei, 230061, China

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Hengyang, 421001, China

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Heze, 274099, China

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Hohhot, 750306, China

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Huizhou, 516002, China

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Jinan, 250013, China

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Jinan, 250021, China

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Jinhua, 321000, China

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Linhai, 317000, China

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Loudi, 417099, China

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Nanchang, 330006, China

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Nanchong, 637000, China

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Nanjing, 2100008, China

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Nanjing, 211100, China

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Nanning, 530000, China

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Nanning, 530021, China

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Pingxiang, 337055, China

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Qingdao, 266011, China

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Qingyuan, 511518, China

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Sanya, 572000, China

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Shanghai, 200040, China

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Shanghai, 200120, China

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Shanghai, 201199, China

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Shanghai, 310000, China

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Shantou, 515041, China

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Shenyang, 110004, China

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Shenzhen, 518020, China

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Shijiazhuang, 50051, China

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Suining Shi, 629000, China

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Taiyuan, 030001, China

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Taiyuan, 030032, China

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Taizhou, 318000, China

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Tianjin, 300050, China

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Wenzhou, 325027, China

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Wuhan, 430022, China

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Wuhan, 430030, China

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Xinxiang, 453100, China

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Xuzhou, 221000, China

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Xuzhou, 221009, China

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Yangzhou, 225001, China

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Yichang, 443003, China

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Yinchuan, 750001, China

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Yinchuan, 750004, China

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Zhangzhou, 363099, China

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Brandýs nad Labem, 250 01, Czechia

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Brno, 625 00, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Lovosice, 410 02, Czechia

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Ostrava, 700 30, Czechia

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Pilsen, 301 00, Czechia

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Prague, 110 00, Czechia

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Prague, 15300, Czechia

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Teplice, 415 01, Czechia

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Varnsdorf, 407 47, Czechia

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København NV, 2400, Denmark

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Bendorf, 56170, Germany

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Berlin, 10787, Germany

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Haltern am See, 45721, Germany

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Hanover, D-30173, Germany

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Immenhausen, 34376, Germany

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Lübeck, 23552, Germany

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Marburg, 35037, Germany

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Rosenheim, 83022, Germany

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Wiesbaden, 65183, Germany

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Ahmedabad, 380053, India

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Ahmedabad, 380054, India

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Belagavi, 590010, India

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Coimbatore, 641028, India

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Dehradun, 248001, India

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Delhi, 110029, India

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Delhi, 110029, India

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Dwārka, 110075, India

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Faridabad, 121012, India

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Gurgaon, 122001, India

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Kochi, 682027, India

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Kolkata, 700053, India

SUSPENDED

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Kozhikode, 673008, India

NOT YET RECRUITING

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Lucknow, 226003, India

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Madurai, 625107, India

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Mysuru, 570002, India

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Nagpur, 440012, India

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Nagpur, 441108, India

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Pune, 411 018, India

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Telangana, 500004, India

NOT YET RECRUITING

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Vadodara, 391760, India

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Cona, 44124, Italy

NOT YET RECRUITING

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Florence, 50134, Italy

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Milan, 20122, Italy

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Montebelluna, 31044, Italy

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Naples, 80131, Italy

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Pavia, 27100, Italy

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Roma, 00128, Italy

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Sassari, 07100, Italy

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Telese Terme, 82037, Italy

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Tradate, 21049, Italy

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Alor Star, 5460, Malaysia

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Kajang, 43000, Malaysia

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Kota Kinabalu, 88200, Malaysia

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Kuala Lumpur, 50603, Malaysia

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Kuala Terengganu, 20400, Malaysia

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Kuantan, 25100, Malaysia

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Kuching, 93586, Malaysia

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Benito Juárez, 03650, Mexico

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Chihuahua City, 31000, Mexico

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Cuauhtémoc, 06700, Mexico

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Cuernavaca, 62290, Mexico

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Guadalajara, 44130, Mexico

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Mérida, 97130, Mexico

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Monterrey, 64310, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 64465, Mexico

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Morelia, 58000, Mexico

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Oaxaca City, 68020, Mexico

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San Juan del Río, 76800, Mexico

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Tijuna, 22010, Mexico

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Veracruz, 91900, Mexico

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Zapopan, 45070, Mexico

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Zapopan, 45138, Mexico

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Iloilo City, 5000, Philippines

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Las Piñas, 1742, Philippines

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Manadaluyong City, 1552, Philippines

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Manila, 1000, Philippines

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Marilao, 3019, Philippines

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Quezon City, 1100, Philippines

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Quezon City, 1100, Philippines

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Tondo, 1012, Philippines

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Bialystok, 15-044, Poland

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Bydgoszcz, 85-231, Poland

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Bydgoszcz, 85-796, Poland

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Chrzanów, 32-500, Poland

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Karczew, 05-480, Poland

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Katowice, 40-648, Poland

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Kielce, 25-426, Poland

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Krakow, 31-513, Poland

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Lodz, 91-211, Poland

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Lublin, 20-011, Poland

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Ostróda, 14-100, Poland

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Piaseczno, 05-500, Poland

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Poznan, 60-693, Poland

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Pruszków, 05-800, Poland

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Płock, 09-407, Poland

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Humenné, 066 01, Slovakia

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Košice, 04011, Slovakia

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Levice, 93401, Slovakia

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Martin, 03659, Slovakia

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Trnava, 91701, Slovakia

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Anyang-si, 14068, South Korea

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Daegu, 42415, South Korea

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Iksan-si, 54538, South Korea

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Jeonju, 54907, South Korea

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Seoul, 06591, South Korea

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Seoul, 06973, South Korea

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Seoul, 08308, South Korea

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Seoul, 135-710, South Korea

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Seoul, 143-729, South Korea

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Seoul, 150-713, South Korea

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Uijeongbu-si, 11765, South Korea

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Wŏnju, 26426, South Korea

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Barakaldo, 48903, Spain

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Barcelona, 08036, Spain

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Granada, 18014, Spain

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Madrid, 28007, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 07010, Spain

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Pamplona, 31008, Spain

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Seville, 41013, Spain

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Valencia, 46010, Spain

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Bradford, BD9 6RJ, United Kingdom

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Brighton, BN2 1ES, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Halifax, HX3 0PW, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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Tyne and Wear, NE29 8NH, United Kingdom

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Wakefield, WF1 4DG, United Kingdom

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dave Singh, MD

  Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a ratio of 1:1:1 to receive Dose 1 of tezepelumab, Dose 2 of tezepelumab or matching placebo.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 19, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): March 13, 2029
• Study Completion (Estimated): June 5, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DK (1); DE (9); PL (15); CZ (10); ME (16); KR (12); US (67); SL (5); PH (8); GB (9); ES (9); CN (62); CL (9); CA (16); IN (21); IT (10); MY (7); BR (15)