AsthmaPhase 2NCT00483041
A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528
A Phase 2 study testing MEDI528 9 mg/kg in people with Asthma, run by MedImmune LLC at 4 sites in United States.
Trial summary
To evaluate the effect of MEDI-528 in adults with atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI528 9 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults, age 18 through 50 years of age at time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning any study procedures;
- Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (eg, chronic obstructive pulmonary disease) ruled out;
- Forced expiratory volume in one second (FEV1) ≥ 70% of predicted value;
- A positive skin prick or intradermal test to cat allergen extract, short ragweed allergen extract, or dust mite allergen extracts. A positive skin test is defined as the indurations of skin test wheal being at least 2 mm greater in diameter than that of the indurations of the control skin wheal;
- History of asthmatic symptoms upon exposure to at least one of the allergens (cat allergen extract, short ragweed allergen extract, or dust mite allergen extracts) that induces a positive skin prick test;
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- AHR on methacholine inhalation challenge test, with PC20 ≤ 8 mg/mL (Crapo, 2000);
- No significant changes in regular asthma medications and no acute asthma exacerbations requiring oral corticosteroids or doubling of ICS dosage, hospitalization, emergency room visits, or unscheduled health care provider visits for asthma for at least 6 weeks prior to screening and up through the time of study drug administration;
- No history of intubation or admission to an intensive care unit for asthma;
- Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the study drug administration on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
- Able to follow study procedures including the ability to provide spirometry readings that meet American Thoracic Society (ATS)/European Respiratory Society (ERS) standards (Miller, 2005);
- Ability to complete the study period, including follow-up period, of up to 126 days; and
- Willing to forego other forms of experimental treatment and study procedures during study.
Who cannot join
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or reaction to any component of the study drug formulation or other medications, such as topical lidocaine, administered during bronchoscopy;
- Lung disease other than allergic asthma (eg, chronic bronchitis);
- FEV1 < 70% of predicted values;
- Use of systemic immunosuppressive drugs including systemic corticosteroids (topical corticosteroids are permitted), ICS at doses > 800 μg/day budesonide or equivalent, long-acting β2 agonists (eg, salmeterol), leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline, omalizumab, or any other medication for asthma except short-acting β2 agonist (as needed) within the 4 weeks prior to screening up through administration of study drug;
- Current use of any β-adrenergic antagonist (eg, propranolol);
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- Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period;
- Upper or lower respiratory tract infections within 8 weeks before screening;
- Acute illnesses or evidence of clinically significant active infection, such as fever ≥ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
- Current allergy vaccination therapy (desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline segmental allergen challenge. The allergy vaccination must not include desensitization to the allergen that will be used in the segmental allergen challenge;
- Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to study drug administration through Study Day 126;
- Receipt of any therapy with a leukocyte-depleting agent (eg, rituximab, alemtuzumab) unless recovery in white cell count has been documented before screening;
- Pregnancy (sexually active females must have negative serum and urine pregnancy tests at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Is a nursing mother at the time of screening;
- Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
- History of significant systemic disease (eg, cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
- History of cancer other than basal cell carcinoma or cervical carcinoma-in-situ treated with apparently successful curative therapy (remission for ≥ 1 year prior to screening);
- History of primary immunodeficiency;
- History of pancreatitis or currently active gastroduodenal ulcer;
- History of coagulation disorders or abnormal PT and PTT test results at screening;
- History of life-long urinary retention;
- History of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to screening or history of smoking of ≥ 10 pack-years;
- History of anaphylaxis;
- Elective surgery planned from the time of screening through Study Day 126;
- Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
- Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
- At the time of screening, any of the following: hemoglobin, total white blood cell count (WBC), platelet count, sodium (Na), potassium (K), chloride (Cl), or carbon dioxide (CO2)out of the normal range; aspartate transaminase (AST), alanine transaminase (ALT), blood urea nitrogen (BUN), amylase, lipase, or serum creatinine above the upper limits of normal (ULN); or other abnormal laboratory values in the screening panel that are judged by the principal investigator to be clinically significant; or
- No detectable levels of IL-9 in the Baseline Visit 2' BAL sample, or any finding upon physical examination or history of any disease that, in the opinion of the principal investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham & Women's Hospital Asthma Research
Boston, Massachusetts, 02115-6106
University of Wisconsin, Section of Allergy, Pulmonary & Critical Care
Madison, Wisconsin, 53792
Washington Univeristy School of Medicine, Division of Pulmonary and Critical Care Medicine
St Louis, Missouri, 63110
Wake Forest University, Baptist Medicial Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, on Allergen-Induced Interleukin-9 Levels in Bronchoalveolar Lavage Fluid in Adults With Atopic Asthma
To evaluate the effect of MEDI-528 in adults with atopic asthma.
Read the detailed description
To evaluate the effect of MEDI-528 on the change in biologically active IL-9 levels in BAL fluid following segmental allergen challenge in adults with atopic asthma.
- Conditions
- Asthma
- Being tested
- PLACEBO, MEDI528 9 mg/kg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBOOther
Placebo administered as a single intravenous infusion
MEDI528 9 mg/kgBiological
MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| MEDI528 9 mg/kg | Experimental | MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion Receives: Biological: MEDI528 9 mg/kg |
| PLACEBO | Placebo comparator | Placebo administered as a single intravenous infusion Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)
The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.
Measured: Baseline (2 to 4 weeks prior to Day 0) and Day 15
Secondary outcomes (12)
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Measured: Days 0 - 126
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Measured: Days 0 - 126
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Measured: Days 0, 28, 56, 84, and 126
Time to Peak Concentration (Tmax)
Tmax of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Peak Concentration (Cmax)
Cmax of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Clearance (CL)
CL of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Terminal Half-life (T1/2)
T1/2 of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Volume at Steady State (Vss)
Vss of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Volume at Distribution (Vz)
Vz of MEDI-528
Measured: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionJun 2009
Why it stopped: Study is replaced by MI-CP198 per CPM.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Parker, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483041
- Sponsor's protocol ID
- MI-CP139
- Status last verified
- Feb 2014
- First submitted
- 4 Jun 2007
- Last updated
- 7 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, on Allergen-Induced Interleukin-9 Levels in Bronchoalveolar Lavage Fluid in Adults With Atopic Asthma
- ClinicalTrials.gov ID
- NCT00483041
- Acronym / sponsor ID
- MI-CP139
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is replaced by MI-CP198 per CPM.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of MEDI-528 in adults with atopic asthma.
Detailed description
To evaluate the effect of MEDI-528 on the change in biologically active IL-9 levels in BAL fluid following segmental allergen challenge in adults with atopic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI528 9 mg/kg | Experimental | Biological: MEDI528 9 mg/kgMEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion |
| PLACEBO | Placebo comparator | Other: PLACEBOPlacebo administered as a single intravenous infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female adults, age 18 through 50 years of age at time of screening;
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning any study procedures;
- Previously documented diagnosis of asthma based on episodic symptoms of airflow obstruction such as wheezing or chest tightness, with alternative diagnoses (eg, chronic obstructive pulmonary disease) ruled out;
- Forced expiratory volume in one second (FEV1) ≥ 70% of predicted value;
- A positive skin prick or intradermal test to cat allergen extract, short ragweed allergen extract, or dust mite allergen extracts. A positive skin test is defined as the indurations of skin test wheal being at least 2 mm greater in diameter than that of the indurations of the control skin wheal;
Key exclusion criteria (28 listed)
- Receipt of MEDI-528 in any previous clinical study;
- History of allergy or reaction to any component of the study drug formulation or other medications, such as topical lidocaine, administered during bronchoscopy;
- Lung disease other than allergic asthma (eg, chronic bronchitis);
- FEV1 < 70% of predicted values;
- Use of systemic immunosuppressive drugs including systemic corticosteroids (topical corticosteroids are permitted), ICS at doses > 800 μg/day budesonide or equivalent, long-acting β2 agonists (eg, salmeterol), leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline, omalizumab, or any other medication for asthma except short-acting β2 agonist (as needed) within the 4 weeks prior to screening up through administration of study drug;
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 |
|---|---|---|
| PLACEBOPlacebo administered as a single intravenous infusion | Other | PLACEBO |
| MEDI528 9 mg/kgMEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion | Biological | MEDI528 9 mg/kg |
Primary outcome
Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)
Time frame: Baseline (2 to 4 weeks prior to Day 0) and Day 15
The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.
12 secondary outcomes
Incidence of Adverse Events
Time frame: Days 0 - 126
Incidence of Serious Adverse Events
Time frame: Days 0 - 126
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Time frame: Days 0, 28, 56, 84, and 126
Time to Peak Concentration (Tmax)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Peak Concentration (Cmax)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Clearance (CL)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Terminal Half-life (T1/2)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Volume at Steady State (Vss)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Volume at Distribution (Vz)
Time frame: Days 0, 1, 7, 14, 15, 28, 56, 84, and 126
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Parker, M.D. study director
MedImmune LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI528 9 mg/kg in people with Asthma, run by MedImmune LLC at 4 sites in United States.
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 13 inclusion and 28 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: stopped early, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL) (time frame: Baseline (2 to 4 weeks prior to Day 0) and Day 15). 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 Mar 2014.