> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-efficacy-and-safety-of-5397ae6d-c09e-4c5a-a357-298f08a3c944 > Record changed: 2026-11-04 # A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) NCT06883305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Participants 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Start date 2025-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) Number of sites 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Acronym** EMBARK Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Short title** A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Dates **Completion date** 2029-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **First posted** 2025-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Registry last updated** 2026-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Primary completion date** 2029-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Start date** 2025-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Size and sites **Participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Planned participants** 990 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Number of sites** 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Identifiers **Registry ID** NCT06883305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **ClinicalTrials.gov ID** NCT06883305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-blinded **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Outcomes ### Primary outcomes 1. Annualised rate of moderate or severe COPD exacerbations Timeframe: Baseline up to 76 weeks The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo. ### Secondary outcomes 1. Change from baseline in post-BD FEV1 Timeframe: From baseline to Week 52 Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration 2. Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) Timeframe: From baseline to Week 52 Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. 3. Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score Timeframe: From baseline over 52 weeks Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status. 4. Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit. Timeframe: Baseline up to 76 weeks The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit. 5. Annualised rate of severe COPD exacerbations Timeframe: Baseline up to 76 weeks The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo. 6. Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation Timeframe: Baseline up to 76 Weeks The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo. 7. Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score Timeframe: From baseline over 52 weeks Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status. 8. Change from baseline in the COPD assessment Test (CAT) total score Timeframe: From baseline over 52 weeks Change from baseline in the CAT total score over 52 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status. 9. Clinical meaningful improvement in COPD Assessment Test (CAT) total score Timeframe: From baseline over 52 weeks Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks. CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status. 10. Time to first moderate or severe COPD exacerbation Timeframe: Baseline up to 76 weeks Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks. 11. Time to first severe COPD exacerbation Timeframe: Baseline up to 76 weeks Time to first occurrence of severe COPD exacerbation up to 76 weeks. 12. Pharmacokinetics (PK): Serum trough concentrations Timeframe: Baseline, Week 24, Week 36, Week 52 Serum trough concentrations 13. Immunogenicity of anti-drug antibodies (ADA) Timeframe: Baseline, Week 24, Week 36, Week 52 Incidence of anti-drug antibodies Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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, if triple therapy is considered not appropriate, ≥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. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Sites - Research SiteFoley, United StatesRecruiting - Research SiteMobile, United StatesRecruiting - Research SiteSheffield, United StatesRecruiting - Research SitePhoenix, United StatesNot yet recruiting - Research SitePhoenix, United StatesRecruiting - Research SiteTucson, United StatesWithdrawn - Research SiteGarden Grove, United StatesRecruiting - Research SiteNewport Beach, United StatesRecruiting - Research SiteTorrance, United StatesRecruiting - Research SiteClearwater, United StatesRecruiting - Research SiteCutler Bay, United StatesRecruiting - Research SiteCutler Bay, United StatesRecruiting - Research SiteDeBary, United StatesRecruiting - Research SiteGainesville, United StatesNot yet recruiting - Research SiteHomestead, United StatesRecruiting - Research SiteMiami, United StatesRecruiting - Research SiteMiami, United StatesRecruiting - Research SiteMiami, United StatesRecruiting - Research SiteOrlando, United StatesRecruiting - Research SiteTampa, United StatesRecruiting - Research SiteTampa, United StatesRecruiting - Research SiteAtlanta, United StatesRecruiting - Research SiteLithonia, United StatesRecruiting - Research SiteRincon, United StatesRecruiting - Research SiteMeridian, United StatesNot yet recruiting And 280 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06883305) ## Related records ### Drugs (1) - [Tezepelumab](https://trialight.com/data/asset/tezepelumab-8dc36556-e99a-4122-9017-127f366a520e.md) ### Collaborators (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition ### Targets (1) - [TSLP](https://trialight.com/data/target/tslp-057bc96b-1ea4-5177-a6e4-25ad3ec5d86e.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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