COPDPhase 2NCT05320939
Immunological Basis for Mepolizumab Activity in COPD
A Phase 2 study testing Mepolizumab 100 MG in people with COPD, run by Temple University.
Trial summary
The current literature suggests that the mode of action of mepolizumab is to bind with Interleukin (IL)-5 and block the interaction of IL-5 with the IL-5Ra receptor on eosinophils. This removal of IL-5 may not explain all of the effects of mepolizumab. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Mepolizumab 100 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to May 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral blood eosinophil count of ≥300 cells/μL from the hematology sample collected and a documented historical blood eosinophil count of ≥300/μL in the 12 months prior.
- Clinically documented history of Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society. A measured pre-and post-salbutamol FEV1/FVC ratio of <0.70.
- Well-documented history (e.g., medical record verification) in the 12 months prior which includes 2 or more moderate COPD exacerbations that were treated with systemic corticosteroids (intramuscular (IM), intravenous, or oral) with or without antibiotics OR at least one severe COPD exacerbation requiring hospitalization.
- Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior.
- A female is eligible if the participant is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP) or 2) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% during the intervention period and for at least 16 weeks after the last dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy urine test within 24 hours before the first dose of study intervention.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Past history or concurrent diagnosis of asthma.
- An α1-antitrypsin deficiency as the underlying cause of COPD are excluded.
- Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within prior 4 weeks.
- Lung volume reduction surgery within the last 12 months.
- Participating in acute phase of a pulmonary rehabilitation program within last 4 weeks.
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- Receiving treatment with oxygen more than 2 Liters(L)/minute at rest over 24 hours. If receiving oxygen treatment, an oxyhemoglobin saturation (as measured by PulseOx) greater than or equal to 89% while breathing supplemental oxygen.
- Myocardial infarction or unstable angina in the prior 6 months.
- Unstable or life threatening cardiac arrhythmia requiring intervention in the prior 3 months.
- New York Heart Association (NYHA) Class IV Heart failure.
- Historical or current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
- Other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis, or Eosinophilic Esophagitis.
- A known pre-existing parasitic infestation within prior 6 months.
- A current malignancy or previous history of cancer in remission for less than 12 months.
- A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken for COPD.
- Cirrhosis or current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
- Received interventional product in previous mepolizumab studies.
- Received any monoclonal antibody within 5 half-lives.
- Received an investigational drug within prior 30 days or within 5 drug half-lives of the investigational drug, whichever is longer.
- Received short term use of oral corticosteroids within prior 30 days.
- A known allergy or sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.
- Participants with, conditions that will limit the validity of informed consent to participate in the study, e.g uncontrolled psychiatric disease or intellectual deficiency.
- A known or suspected history of alcohol or drug abuse within prior 2 years.
- Is an Investigator, sub-Investigator, study coordinator, employee of a participating Investigator or study site, or immediate family member of the aforementioned that is involved in this study
Trial locations and contacts
No sites are listed yet.
About this study
The current literature suggests that the mode of action of mepolizumab is to bind with Interleukin (IL)-5 and block the interaction of IL-5 with the IL-5Ra receptor on eosinophils. This removal of IL-5 may not explain all of the effects of mepolizumab. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.
Read the detailed description
The investigators will recruit a total of 30 Chronic Obstructive Pulmonary Disease (COPD) participants from the Temple University Hospital Lung Center Clinic. All participants will have moderate to severe COPD and have a history of 2 or more acute exacerbations in the past year, and eosinophil counts of greater than 300 cells/ul. The investigators studies will include an analysis of the status of the systemic and lung inflammatory phenotype of the major leukocyte populations, using multiparameter flow cytometry. The investigators will couple these studies with an analysis of a panel of inflammatory and anti-inflammatory biomarkers in both the blood and bronchoalveolar lavage fluid. Very importantly, the investigators will characterize the functional capacity of T cells, B cells, monocytes, and granulocytes during drug therapy. By using this approach, the investigators believe a more complete understanding of the scope of activity of mepolizumab at the level of immune competence will be developed.
- Conditions
- COPD
- Being tested
- Mepolizumab 100 MG
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 100 MGDrug
30 subjects (≥ 300 eosinophils/ul) will receive mepolizumab 100 mg subcutaneously every 4 weeks for 5 complete doses.
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab 100mg | Experimental | The Investigators will recruit a total of 30 subjects for this study (all subjects for the mepolizumab treatment). Receives: Drug: Mepolizumab 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of peripheral blood eosinophil and B cell levels
Peripheral blood eosinophil and B cell number counts
Measured: 6 months
Secondary outcomes (8)
Change from baseline of peripheral blood T cells
Peripheral blood T cell number counts
Measured: 6 months
Change from baseline of peripheral blood monocytes
Peripheral blood monocyte number counts
Measured: 6 months
Change from baseline of peripheral blood neutrophils
Peripheral blood neutrophil cell number counts
Measured: 6 months
Change from baseline of peripheral blood NK cells
Peripheral blood NK cell number counts
Measured: 6 months
Change from baseline of peripheral blood dendritic cells
Peripheral blood dendritic cell number counts
Measured: 6 months
Change from baseline of peripheral blood CCL11 levels
Blood CCL11 pg/ml
Measured: 6 months
Change from baseline of peripheral blood CCL24 levels
Blood CCL24 pg/ml
Measured: 6 months
Change from baseline of peripheral blood CCL26 levels
Blood CCL26 pg/ml
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 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
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot open-label single arm study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Thomas Rogers, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320939
- Sponsor's protocol ID
- ISS Proposal # 12342
- Status last verified
- Apr 2023
- First submitted
- 1 Apr 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Basis for Mepolizumab Activity in COPD
- ClinicalTrials.gov ID
- NCT05320939
- Acronym / sponsor ID
- ISS Proposal # 12342
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 11 Apr 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.
The current literature suggests that the mode of action of mepolizumab is to bind with Interleukin (IL)-5 and block the interaction of IL-5 with the IL-5Ra receptor on eosinophils. This removal of IL-5 may not explain all of the effects of mepolizumab. The investigators propose a set of studies to systematically examine the spectrum of effects of this drug on the immune system.
Detailed description
The investigators will recruit a total of 30 Chronic Obstructive Pulmonary Disease (COPD) participants from the Temple University Hospital Lung Center Clinic. All participants will have moderate to severe COPD and have a history of 2 or more acute exacerbations in the past year, and eosinophil counts of greater than 300 cells/ul. The investigators studies will include an analysis of the status of the systemic and lung inflammatory phenotype of the major leukocyte populations, using multiparameter flow cytometry. The investigators will couple these studies with an analysis of a panel of inflammatory and anti-inflammatory biomarkers in both the blood and bronchoalveolar lavage fluid. Very importantly, the investigators will characterize the functional capacity of T cells, B cells, monocytes, and granulocytes during drug therapy. By using this approach, the investigators believe a more complete understanding of the scope of activity of mepolizumab at the level of immune competence will be developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot open-label single arm study.
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab 100mg | Experimental | Drug: Mepolizumab 100 MGThe Investigators will recruit a total of 30 subjects for this study (all subjects for the mepolizumab treatment). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Peripheral blood eosinophil count of ≥300 cells/μL from the hematology sample collected and a documented historical blood eosinophil count of ≥300/μL in the 12 months prior.
- Clinically documented history of Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society. A measured pre-and post-salbutamol FEV1/FVC ratio of <0.70.
- Well-documented history (e.g., medical record verification) in the 12 months prior which includes 2 or more moderate COPD exacerbations that were treated with systemic corticosteroids (intramuscular (IM), intravenous, or oral) with or without antibiotics OR at least one severe COPD exacerbation requiring hospitalization.
- Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior.
- A female is eligible if the participant is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP) or 2) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% during the intervention period and for at least 16 weeks after the last dose of study intervention.
Key exclusion criteria (24 listed)
- Past history or concurrent diagnosis of asthma.
- An α1-antitrypsin deficiency as the underlying cause of COPD are excluded.
- Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within prior 4 weeks.
- Lung volume reduction surgery within the last 12 months.
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 |
|---|---|---|
| Mepolizumab 100 MG30 subjects (≥ 300 eosinophils/ul) will receive mepolizumab 100 mg subcutaneously every 4 weeks for 5 complete doses. | Drug | Mepolizumab 100mg |
Primary outcome
Change from baseline of peripheral blood eosinophil and B cell levels
Time frame: 6 months
Peripheral blood eosinophil and B cell number counts
8 secondary outcomes
Change from baseline of peripheral blood T cells
Time frame: 6 months
Change from baseline of peripheral blood monocytes
Time frame: 6 months
Change from baseline of peripheral blood neutrophils
Time frame: 6 months
Change from baseline of peripheral blood NK cells
Time frame: 6 months
Change from baseline of peripheral blood dendritic cells
Time frame: 6 months
Change from baseline of peripheral blood CCL11 levels
Time frame: 6 months
Change from baseline of peripheral blood CCL24 levels
Time frame: 6 months
Change from baseline of peripheral blood CCL26 levels
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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.
Thomas Rogers, PhD principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mepolizumab 100 MG in people with COPD, run by Temple University.
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 7 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Thomas Rogers, PhD (215-707-3215, rogerst@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of peripheral blood eosinophil and B cell levels (time frame: 6 months). 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 7 Apr 2023.