Evaluating Tezepelumab for Adults with Moderate to Very Severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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 be randomly assigned to receive either tezepelumab or a placebo through monthly subcutaneous injections over a treatment duration of 52 to 76 weeks. The study aims to include individuals who have experienced multiple COPD exacerbations in the past year while on inhaled maintenance therapy. An off-treatment safety follow-up period of 12 weeks is also included to monitor any long-term effects.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Foley, Alabama, United States Recruiting
• Research Site
  Mobile, Alabama, United States Recruiting
• Research Site
  Sheffield, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Garden Grove, California, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting

+255 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Dave Singh, MD — Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Tezepelumab for Adults with Moderate to Very Severe COPD

  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.

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• Chronic Respiratory Disease Participant Engagement

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  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• IOS-based platform to screen, diagnose, and manage COPD and asthma

  This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT07910409

• Targeted NMES to improve breathing and leg/extra muscle strength in COPD

  This study tests whether targeted neuromuscular electrical stimulation helps people with COPD see improvements in breathing muscle function and overall muscle strength.

  Recruiting Universitas Padjadjaran · Bandung, West Java · NCT07910006

• AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer

  This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.

  Recruiting Phase 2 AeroRx Therapeutics Inc. · London and 1 other locations · NCT07896252

• PBMT with a pulmonary rehab program for COPD patients

  A small randomized trial tests whether adding photobiomodulation therapy before exercise in a COPD pulmonary rehab program helps improve functional capacity.

  Recruiting Federal University of Health Science of Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07878884

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.