At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tezepelumab (biological), Placebo (other)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- Tezepelumab — biological: Tezepelumab 210 mg for 20 weeks (5 doses in total, 4-week intervals), administered subcutaneously · Placebo — other: Placebo subcutaneous injection for 20 weeks (5 doses in total, 4-week intervals)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2022-10-25
- Last checked
- 2024-08
Plain English Summary
What is this study?
- • Testing a new treatment for copd
- • Phase2 - 80 participants
- • A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with copd
Where?
- • Leicester - Research site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
More detail
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD on LABA+LAMA±ICS with ≥ 1 exacerbation the past 12 months. Approximately 80 subjects will be randomized to receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 20-week treatment period.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Written agreement to take part
- ✓A diagnosis of COPD (according to GOLD (GOLD 2021 Report))
- ✓≥ 10 packyears smoked (current or ex-smokers)
- ✓Age 40 years or older
- ✓Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and \< 80% predicted
Who cannot take part
- ✗Current asthma
- ✗Lung volume reduction surgery for COPD
- ✗Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1...
- ✗Any use of home oxygen therapy
- ✗Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to...
See the full criteria
Where Is This Study? (1 UK site)
Research site
Leicester LE3 9QP, United Kingdom
How to Get in Touch
Kristoffer Norheim, PhD
Sponsor contactCONTACT
Asger Sverrild, MD, PhD
Sponsor contactCONTACT
