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New treatment option for COPD
Official title Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
ClinicalTrials.gov ID: NCT05507242
What this study is testing
What is Tezepelumab?
Tezepelumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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 phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
- Phase 2: a mid-size study of how well it works
- 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 and older
You may be able to join if
- Written informed consent
- 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
You likely can't join if
- Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the...
- Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or...
- 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 or during the run-in period
- Any use of home oxygen therapy
See the full eligibility criteria
- Written informed consent
- 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
- Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1
- ≥1 prednisolon and/or antibiotic treated exacerbation in the past 12 months
- people must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)
- people must demonstrate ≥ 70% compliance with daily inhalers during the screening/run-in
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using...
- Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the...
- Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis...
- 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 or during the run-in period
- Any use of home oxygen therapy
- Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put...
- History of cancer: people who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1...
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to Visit 1 or during the screening period
- A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history
- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. people with a history of hepatitis B vaccination without history of...
- History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.
- History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.
- Active tuberculosis or history of untreated latent tuberculosis
- History of anaphylaxis to any biologic therapy.
- Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3...
- Receipt of any of the following within 30 days prior to Visit 1: immunoglobulin or blood products, or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior Visit 1, whichever is longer.
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half- lives prior to Visit 1, whichever is longer.
- Pregnant, breastfeeding or lactating females
- History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
- Planned surgical procedures requiring general anesthesia or in-patient status for \> 1 day during the conduct of the study.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Concurrent enrollment in another clinical study involving an investigational treatment.
- Receipt of any live or attenuated vaccines within 15 days prior to Visit 1.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Leicester, United Kingdom
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Leicester, United Kingdom. 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.