COPDPhase 2UPSTREAM-COPDNCT05507242
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
A Phase 2 study testing Tezepelumab in people with COPD and COPD Exacerbation, run by Asger Sverrild at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, COPD Exacerbation, COPD Bronchitis
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Oct 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ≥1 prednisolon and/or antibiotic treated exacerbation in the past 12 months
- Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)
- Subjects 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 such precautions through Week 20 of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
Who cannot join
- 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 investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
- 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, pulmonary fibrosis, aspergillosis, active tuberculosis).
- 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
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- 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 the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study
- History of cancer: Subjects 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. Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years 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. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
- 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 months prior to Visit 1.
- 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.
Trial locations and contacts
2 sites in 2 countries.
Asger Sverrild, MD, PhD contact
2 sites in 2 countries
United Kingdom1 site, 1 recruiting
- Recruiting
Research site
Leicester, LE3 9QP
About this study
Official title: Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
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.
Read the detailed description
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.
- Conditions
- COPD, COPD Exacerbation, COPD Bronchitis, Airway Disease, Immune System Disorder
- Being tested
- Tezepelumab, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabBiological
Tezepelumab 210 mg for 20 weeks (5 doses in total, 4-week intervals), administered subcutaneously
PlaceboOther
Placebo subcutaneous injection for 20 weeks (5 doses in total, 4-week intervals)
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab | Experimental | Tezepelumab subcutaneous injection Receives: Biological: Tezepelumab |
| Placebo | Placebo comparator | Placebo subcutaneous injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation
The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20
Measured: 20 weeks
Secondary outcomes (5)
To evaluate the effect of tezepelumab on neutrophilic bronchial mucosal tissue inflammation
The change, expressed as ratio, in neutrophil cell couts per mm2 from baseline to week-20
Measured: 20 weeks
To evaluate the effect of tezepelumab on mast cell bronchial mucosal tissue inflammation
The change, expressed as ratio, in mast cell couts per mm2 from baseline to week-20
Measured: 20 weeks
To evaluate the effect of tezepelumab on CD4+ cell bronchial mucosal tissue inflammation
The change, expressed as ratio, in CD4+ cell couts per mm2 from baseline to week-20
Measured: 20 weeks
To evaluate the effect of tezepelumab on CD8+ cell bronchial mucosal tissue inflammation
The change, expressed as ratio, in CD8+ cell couts per mm2 from baseline to week-20
Measured: 20 weeks
To evaluate the effect of tezepelumab on macrophage cell bronchial mucosal tissue inflammation
The change, expressed as ratio, in macrophage cell couts per mm2 from baseline to week-20
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start25 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asger Sverrild
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, University Hospitals, Leicester
- Responsible party
- Sponsor-investigator, Asger Sverrild, Bispebjerg Hospital
- Investigators
- Asger Sverrild, MD, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507242
- Sponsor's protocol ID
- UPSTREAM-COPD
- Acronym
- UPSTREAM-COPD
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
- ClinicalTrials.gov ID
- NCT05507242
- Acronym / sponsor ID
- UPSTREAM-COPD / UPSTREAM-COPD
- Conditions
- COPD, COPD Exacerbation, COPD Bronchitis, Airway Disease, Immune System Disorder
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Asger SverrildUniversity, hospital or other
- Collaborators
- AstraZeneca, University Hospitals, Leicester
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab | Experimental | Biological: TezepelumabTezepelumab subcutaneous injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo subcutaneous injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (24 listed)
- 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 investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
- 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, pulmonary fibrosis, aspergillosis, active tuberculosis).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabTezepelumab 210 mg for 20 weeks (5 doses in total, 4-week intervals), administered subcutaneously | Biological | Tezepelumab |
| PlaceboPlacebo subcutaneous injection for 20 weeks (5 doses in total, 4-week intervals) | Other | Placebo |
Primary outcome
To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation
Time frame: 20 weeks
The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20
5 secondary outcomes
To evaluate the effect of tezepelumab on neutrophilic bronchial mucosal tissue inflammation
Time frame: 20 weeks
To evaluate the effect of tezepelumab on mast cell bronchial mucosal tissue inflammation
Time frame: 20 weeks
To evaluate the effect of tezepelumab on CD4+ cell bronchial mucosal tissue inflammation
Time frame: 20 weeks
To evaluate the effect of tezepelumab on CD8+ cell bronchial mucosal tissue inflammation
Time frame: 20 weeks
To evaluate the effect of tezepelumab on macrophage cell bronchial mucosal tissue inflammation
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asger Sverrild, MD, PhD contact
Asger Sverrild, MD, PhD principal investigator
Bispebjerg Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tezepelumab in people with COPD and COPD Exacerbation, run by Asger Sverrild at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer Norheim, PhD (+4542831337, kristoffer.norheim@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.