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Tests treatment safety and results for Chronic Obstructive Pulmonary Disease (COPD)
Official title A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
ClinicalTrials.gov ID: NCT06878261
What this study is testing
What is Tezepelumab?
Tezepelumab is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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...
You likely can't join 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)
See the full eligibility criteria
- ≥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...
- EOS ≥ 150 cells/μL during screening
- CAT ≥15 at screening
- Former or current smokers ≥10 pack-years
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Inglewood, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Redding, California, United States
- San Diego, California, United States
- New Britain, Connecticut, United States
- Wilmington, Delaware, United States
- Bay Pines, Florida, United States
- Boynton Beach, Florida, United States
- Clearwater, Florida, United States
- Fleming Island, Florida, United States
- Jacksonville, Florida, United States
- Leesburg, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Ocala, Florida, United States
+ 204 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Inglewood, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 218 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.