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Evaluating Tezepelumab for Adults with Moderate to Very Severe COPD

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

Phase 3 Interventional AstraZeneca · NCT06878261

This study is testing if a new medication called tezepelumab can help adults with moderate to very severe COPD feel better and reduce their flare-ups over a treatment period of up to 76 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment990 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsTezepelumab
Locations268 sites (Cullman, Alabama and 267 other locations)
Trial IDNCT06878261 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy and safety of tezepelumab in adults diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants will receive either tezepelumab or a placebo through monthly subcutaneous injections over a treatment duration of up to 76 weeks. The study aims to enroll individuals who have experienced multiple COPD exacerbations in the past year while on inhaled maintenance therapy. Safety follow-up will occur for 12 weeks after treatment completion.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with a diagnosis of COPD who have had multiple exacerbations in the past year.

Not a fit: Patients with other significant pulmonary diseases or those with asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of COPD and reduce exacerbations in affected patients.

How similar studies have performed: Previous studies have shown promising results with similar monoclonal antibody approaches in treating COPD, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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, 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

Where this trial is running

Cullman, Alabama and 267 other locations

+218 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseCOPDModerate COPDSevere COPDVery Severe COPDchronic obstructive pulmonary disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.