AsthmaPhase 2NCT00783289
A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
A Phase 2 study testing Benralizumab 25 mg, Benralizumab 100 mg and Benralizumab 200 mg in people with Asthma, run by MedImmune LLC at 6 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab 25 mg, Benralizumab 100 mg and Benralizumab 200 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Nov 2008to 17 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects
- Age 18 through 80 years at screening
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Previously documented diagnosis of asthma of more than or equal to (>=) 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction >=12 percent (%) (at screening or documented within 1 year prior to randomization); or proof of a positive response to a methacholine challenge (documented within 1 year prior to randomization) as represented by a provoking concentration of methacholine to cause a 20% fall in forced expiratory volume in 1 second (FEV1); (PC20) less than (<) 8 milligram per milliliter (mg/mL)
- Weight of >=45 kilogram (kg) but less than or equal to (<=) 135 kg (>=100 pounds [lb] but <=300 lb)
- Able to produce spirometry readings that meet American Thoracic Society (ATS)/European Respiratory Society (ERS) standards
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- Screening pre-bronchodilator FEV1 >=60%
- Women of childbearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) for 14 days prior to the first dose of the investigational product on Study Day 0, and must agree to continue using such precautions through Study Day 161. Cessation of birth control after this point should be discussed with a responsible physician
- Men, unless surgically sterile, must likewise use 2 effective methods of birth control (for example, condom with spermicide) and must agree to continue using such contraceptive precautions through End of Study/Study Day 161
- Ability to complete the study period, including follow-up period until Study Day 161 as required by protocol
Who cannot join
- Previously received benralizumab (MEDI-563)
- History of allergy or reaction to any component of the investigational product formulation
- History of allergy or reaction to any other marketed or experimental monoclonal antibody therapies, intravenous gammaglobulin (IVIG), or blood products
- Receipt of any investigational drug therapy within 30 days prior to randomization into the study or any biologic(s) within 5 half-lives of the agent prior to randomization into the study
- Treatment with an oral or systemic burst of corticosteroids within 4 weeks prior to randomization into the study
- Use of any chronic systemic immunosuppressive drugs, including oral corticosteroids within 4 weeks prior to randomization into the study
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- Current use of any oral or ophthalmic beta-adrenergic antagonist (for example, propranolol), must have been stopped 2 weeks prior to randomization into the study
- Current allergy vaccination (immunotherapy)
- History of anaphylaxis
- Lung disease other than persistent asthma (for example, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease [COPD], tuberculosis [TB])
- Acute illnesses or evidence of significant active infection, such as fever >=38.0 degrees Celsius [C] (>=100.5 degrees Fahrenheit [F]) at screening and up through time of the first dose of the investigational product
- History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or an untreated parasitic infection within 1 month of randomization
- Pregnancy (women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the investigational product)
- Lactating woman
- Infection with human immunodeficiency virus (HIV)-1, HIV-2, or hepatitis A, B, or C virus
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >= 1 year prior to randomization into the study
- History of cigarette smoking >=10 pack years
- History of alcohol abuse or drug abuse that required treatment <1 year prior to randomization into the study
- Elective surgery planned during the study period
- Evidence of any systemic disease or any finding upon physical examination, laboratory abnormality, chest x-ray (CXR), or electrocardiogram (ECG) that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study results
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or first degree family members of such individuals (that is, parents, siblings, or children)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Colorado Springs, Colorado
Research Site
Encinitas, California
Research Site
Los Angeles, California
Allergy Associates Research Center
Portland, Oregon, 97213
Research Site
Upland, Pennsylvania
Research Site
Wheaton, Maryland
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple-dose Subcutaneous Administration of MEDI-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults With Asthma
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.
Read the detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of multiple subcutaneous doses (25, 100, or 200 milligram [mg]) of benralizumab (MEDI-563) in adult subjects with asthma.
- Conditions
- Asthma
- Being tested
- Placebo, Benralizumab 25 mg, Benralizumab 100 mg, Benralizumab 200 mg
- Keywords
- Asthma, Benralizumab, MEDI-563
- 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 matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.
Benralizumab 25 mgBiological
Also called MEDI-563
Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.
Benralizumab 100 mgBiological
Also called MEDI-563
Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.
Benralizumab 200 mgBiological
Also called MEDI-563
Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56. Receives: Other: Placebo |
| Benralizumab 25 mg | Experimental | Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. Receives: Biological: Benralizumab 25 mg |
| Benralizumab 100 mg | Experimental | Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. Receives: Biological: Benralizumab 100 mg |
| Benralizumab 200 mg | Experimental | Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. Receives: Biological: Benralizumab 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 0 to Day 161
Secondary outcomes (5)
Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab
Measured: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Maximum Observed Serum Concentration (Cmax) for Benralizumab
Measured: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab
Area under the serum concentration-time curve from time-zero extrapolated to infinity postdose.
Measured: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
Terminal phase elimination half-life (t1/2) is the time measured for the serum concentration to decrease by one half.
Measured: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit
Measured: Day 0, 28, 56, 84, 112, and 161
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start14 Nov 2008
- Primary completion17 Nov 2009
- Study completion17 Nov 2009
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gossage, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783289
- Sponsor's protocol ID
- MI-CP197
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2008
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple-dose Subcutaneous Administration of MEDI-563, a Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, in Adults With Asthma
- ClinicalTrials.gov ID
- NCT00783289
- Acronym / sponsor ID
- MI-CP197
- Conditions
- Asthma
- Keywords
- Asthma, Benralizumab, MEDI-563
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2008 (actual)
- Primary completion
- 17 Nov 2009 (actual)
- Study completion
- 17 Nov 2009 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 27 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.
Detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of multiple subcutaneous doses (25, 100, or 200 milligram [mg]) of benralizumab (MEDI-563) in adult subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56. |
| Benralizumab 25 mg | Experimental | Biological: Benralizumab 25 mgBenralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. |
| Benralizumab 100 mg | Experimental | Biological: Benralizumab 100 mgBenralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. |
| Benralizumab 200 mg | Experimental | Biological: Benralizumab 200 mgBenralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects
- Age 18 through 80 years at screening
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Previously documented diagnosis of asthma of more than or equal to (>=) 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction >=12 percent (%) (at screening or documented within 1 year prior to randomization); or proof of a positive response to a methacholine challenge (documented within 1 year prior to randomization) as represented by a provoking concentration of methacholine to cause a 20% fall in forced expiratory volume in 1 second (FEV1); (PC20) less than (<) 8 milligram per milliliter (mg/mL)
- Weight of >=45 kilogram (kg) but less than or equal to (<=) 135 kg (>=100 pounds [lb] but <=300 lb)
Key exclusion criteria (21 listed)
- Previously received benralizumab (MEDI-563)
- History of allergy or reaction to any component of the investigational product formulation
- History of allergy or reaction to any other marketed or experimental monoclonal antibody therapies, intravenous gammaglobulin (IVIG), or blood products
- Receipt of any investigational drug therapy within 30 days prior to randomization into the study or any biologic(s) within 5 half-lives of the agent prior to randomization into the study
- Treatment with an oral or systemic burst of corticosteroids within 4 weeks prior to randomization into the study
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 matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56. | Other | Placebo |
| Benralizumab 25 mgAlso: MEDI-563Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56. | Biological | Benralizumab 25 mg |
| Benralizumab 100 mgAlso: MEDI-563Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56. | Biological | Benralizumab 100 mg |
| Benralizumab 200 mgAlso: MEDI-563Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56. | Biological | Benralizumab 200 mg |
Primary outcome
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 0 to Day 161
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 161 that were absent before treatment or that worsened relative to pre-treatment state.
5 secondary outcomes
Time to Reach Maximum Observed Serum Concentration (Tmax) for Benralizumab
Time frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Maximum Observed Serum Concentration (Cmax) for Benralizumab
Time frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Area Under the Curve From Time 0 to Infinity (AUC [0-infinity]) for Benralizumab
Time frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Terminal Phase Elimination Half-Life (t1/2) for Benralizumab
Time frame: Day 0, 1, 7, 28, 35, 56, 84, 112, and 161
Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Benralizumab at Any Visit
Time frame: Day 0, 28, 56, 84, 112, and 161
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Attachments tab: MI-CP197 Redacted Protocol\_22\_Jul\_2015Link provided by the sponsor.
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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.
David Gossage, M.D. study director
MedImmune LLC
6 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 Benralizumab 25 mg, Benralizumab 100 mg and Benralizumab 200 mg in people with Asthma, run by MedImmune LLC at 6 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 27 Dec 2019). 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?
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 0 to Day 161). 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 27 Dec 2019.