Chronic Obstructive Pulmonary Disease study: Tezepelumab
Official title A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
ClinicalTrials.gov ID: NCT06883305
What this study is testing
What is Tezepelumab?
An investigational once‑monthly injectable medicine being studied for moderate to very severe 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
- The study wants to find out if tezepelumab improves lung function and safety in people with moderate to very severe COPD.
- Who it's for
- Adults who have moderate to very severe COPD.
- What's involved
- Participants will receive either tezepelumab or a placebo, and will have regular clinic visits and lung function tests.
- Time commitment
- The study lasts about 12 months, with several clinic visits and tests scheduled throughout that time.
- 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
- Macrolides (less than 6 months)
- Systemic immuno-suppressive, -modulating medications
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.
- 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
- 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 is enrolling
- Foley, Alabama, United States
- Mobile, Alabama, United States
- Sheffield, Alabama, United States
- Phoenix, Arizona, United States
- Garden Grove, California, United States
- Newport Beach, California, United States
- Torrance, California, United States
- Clearwater, Florida, United States
- Cutler Bay, Florida, United States
- DeBary, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Lithonia, Georgia, United States
- Rincon, Georgia, United States
- Palos Hills, Illinois, United States
- Winfield, Illinois, United States
- Munster, Indiana, 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, but 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?
This study is enrolling now at Foley, Alabama, United States; Mobile, Alabama, United States; Sheffield, Alabama, United States; Phoenix, Arizona, United States; Garden Grove, California, United States; Newport Beach, California, United States and 218 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.