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AsthmaPhase 3MELTEMINCT02808819

A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 178 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542). Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Asthma
What is being tested?
Benralizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
178 sitesin 15 countries
Study dates
30 Jun 2016to 18 Jun 2020
Phase
Phase 3
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 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
  • Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
  • Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
  • For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
  • All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.

Who cannot join

  • Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
  • Affect the safety of the patient throughout the study
  • Influence the findings of the study or their interpretations
  • Impede the patient's ability to complete the entire duration of study
  • A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy
  • Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study
Show all 16Show fewer
  • Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
  • Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP
  • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
  • Planned major surgical procedures during the conduct of the study
  • Previous participation in the present study
  • Concurrent enrolment in another drug-related interventional clinical trial
  • AstraZeneca staff involved in the planning and/or conduct of the study
  • Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
  • Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
  • Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved

Trial locations and contacts

178 sites in 15 countries.

178 sites in 15 countries

United States52 sites

  • Research Site

    Abingdon, Virginia, 24210

  • Research Site

    Bakersfield, California, 93301

  • Research Site

    Bangor, Maine, 04401

  • Research Site

    Cincinnati, Ohio, 45231

  • Research Site

    Clearwater, Florida, 33765

  • Research Site

    Colorado Springs, Colorado, 80907

  • Research Site

    Dallas, Texas, 75225

  • Research Site

    Dallas, Texas, 75235

  • Research Site

    Denver, Colorado, 80206

  • Research Site

    Doral, Florida, 33172

  • Research Site

    Durham, North Carolina, 27705

  • Research Site

    Falls Church, Virginia, 22044

  • Research Site

    Farmington Hills, Michigan, 48334

  • Research Site

    Flint, Michigan, 48504

  • Research Site

    Glendale, Arizona, 85306

  • Research Site

    Hialeah, Florida, 33012

  • Research Site

    Hodges, South Carolina, 29653

  • Research Site

    Houston, Texas, 77058

  • Research Site

    Houston, Texas, 77081

  • Research Site

    Houston, Texas, 77083

  • Research Site

    Iowa City, Iowa, 52242

  • Research Site

    Jefferson Hills, Pennsylvania, 15025

  • Research Site

    Madison, Wisconsin, 53792

  • Research Site

    McKinney, Texas, 75069

  • Research Site

    Miami, Florida, 33134

  • Research Site

    Miami, Florida, 33144

  • Research Site

    Miami, Florida, 33176

  • Research Site

    Middleburg Heights, Ohio, 44130

  • Research Site

    New Haven, Connecticut, 06520

  • Research Site

    New York, New York, 10016

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    Oklahoma City, Oklahoma, 73103

  • Research Site

    Oklahoma City, Oklahoma, 73120

  • Research Site

    Orlando, Florida, 32819

  • Research Site

    Orlando, Florida, 32825

  • Research Site

    Philadelphia, Pennsylvania, 19140

  • Research Site

    Phoenix, Arizona, 85012

  • Research Site

    Quincy, Massachusetts, 02169

  • Research Site

    Rapid City, South Dakota, 57702

  • Research Site

    Redondo Beach, California, 90277

  • Research Site

    Roseville, California, 95661

  • Research Site

    Sacramento, California, 95825

  • Research Site

    San Jose, California, 95117

  • Research Site

    Scottsboro, Alabama, 35768

  • Research Site

    Stockton, California, 95204

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Traverse City, Michigan, 49686

  • Research Site

    Westminster, California, 92683

  • Research Site

    Wheat Ridge, Colorado, 80033

  • Research Site

    Winston-Salem, North Carolina, 27103

  • Research Site

    Winter Park, Florida, 32789

  • Research Site

    Woodland, California, 95695

Other trials in United States

Poland33 sites

  • Research Site

    Aleksandrów Łódzki, 95-070

  • Research Site

    Bialystok, 15-430

  • Research Site

    Bydgoszcz, 85-168

  • Research Site

    Dobre Miasto, 11-040

  • Research Site

    Gdansk, 80-214

  • Research Site

    Gorzów Wlkp, 66-400

  • Research Site

    Grodzisk Mazowiecki, 05-825

  • Research Site

    Kościan, 64-000

  • Research Site

    Krakow, 31-011

  • Research Site

    Krakow, 31-033

  • Research Site

    Lodz, 90-141

  • Research Site

    Lodz, 91-103

  • Research Site

    Lubin, 59-300

  • Research Site

    Lublin, 20-552

  • Research Site

    Ostrów Wielkopolski, 63-400

  • Research Site

    Poznan, 60-685

  • Research Site

    Poznan, 60-693

  • Research Site

    Poznan, 60-823

  • Research Site

    Proszowice, 32-100

  • Research Site

    Ruda Śląska, 41-709

  • Research Site

    Rzeszów, 35-205

  • Research Site

    Skierniewice, 96-100

  • Research Site

    Sosnowiec, 41-200

  • Research Site

    Tarnów, 33-100

  • Research Site

    Trzebnica, 55-100

  • Research Site

    Warsaw, 01-138

  • Research Site

    Warsaw, 01-868

  • Research Site

    Wieluń, 98-300

  • Research Site

    Wołomin, 05-200

  • Research Site

    Wroclaw, 50-220

  • Research Site

    Wroclaw, 51-162

  • Research Site

    Wroclaw, 53-301

  • Research Site

    Żnin, 88-400

Other trials in Poland

Germany14 sites

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Bamberg, 96049

  • Research Site

    Berlin, 10367

  • Research Site

    Frankfurt, 60596

  • Research Site

    Frankfurt am Main, 60389

  • Research Site

    Geesthacht, 21502

  • Research Site

    Großhansdorf, 20927

  • Research Site

    Hamburg, 22299

  • Research Site

    Hanover, D-30173

  • Research Site

    Leipzig, 04103

  • Research Site

    Leipzig, 04207

  • Research Site

    Mainz, 55131

  • Research Site

    Marburg, 30625

  • Research Site

    Rüdersdorf, 15562

Other trials in Germany

France12 sites

  • Research Site

    Brest, 29609

  • Research Site

    Dijon, 21079

  • Research Site

    Le Kremlin-Bicêtre, 94275

  • Research Site

    Le Mans, 72037

  • Research Site

    Lyon, 69317

  • Research Site

    Marseille, 13915

  • Research Site

    Montpellier, 34295

  • Research Site

    Paris, 75018

  • Research Site

    Pringy, 74374

  • Research Site

    Saint-Pierre, 97448

  • Research Site

    Strasbourg, 67091

  • Research Site

    Toulouse, 31059

Other trials in France

Ukraine10 sites

  • Research Site

    Dnipro, 49006

  • Research Site

    Ivano-Frankivsk, 76018

  • Research Site

    Kharkiv Region, 61022

  • Research Site

    Kharkiv Region, 61035

  • Research Site

    Kharkiv Region, 61039

  • Research Site

    Kharkiv Region, 61058

  • Research Site

    Kyiv, 03680

  • Research Site

    Kyiv, 04201

  • Research Site

    Lutsk, 4300

  • Research Site

    Vinnytsia, 21029

Other trials in Ukraine

Canada9 sites

  • Research Site

    Calgary, Alberta, T2N 4Z6

  • Research Site

    Hamilton, Ontario, L8N 4A6

  • Research Site

    Montreal, Quebec, H2W 1T8

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Ottawa, Ontario, K1G 6C6

  • Research Site

    Québec, Quebec, G1G 3Y8

  • Research Site

    Québec, Quebec, G1V 4G5

  • Research Site

    Sherwood Park, Alberta, T8L 0N2

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Russia9 sites

  • Research Site

    Nizhny Novgorod, 603126

  • Research Site

    Saint Petersburg, 196247

  • Research Site

    Saratov, 410053

  • Research Site

    Smolensk, 214019

  • Research Site

    Vladikavkaz, 362007

  • Research Site

    Volgograd, 400001

  • Research Site

    Volgograd, 400131

  • Research Site

    Yekaterinburg, 620039

  • Research Site

    Yekaterinburg, 620149

Other trials in Russia

Bulgaria6 sites

  • Research Site

    Pazardzhik, 4400

  • Research Site

    Pernik, 2300

  • Research Site

    Petrich, 2850

  • Research Site

    Rousse, 7002

  • Research Site

    Sliven, 8800

  • Research Site

    Vratsa, 3000

Other trials in Bulgaria

Spain6 sites

  • Research Site

    Málaga, 29010

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Sagunto(Valencia), 46520

  • Research Site

    Salamanca, 37007

  • Research Site

    Valencia, 46015

  • Research Site

    Valencia, 46017

Other trials in Spain

United Kingdom6 sites

  • Research Site

    Birmingham, B9 5SS

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Chertsey, B9 5SS

  • Research Site

    Cottingham, HU16 5JQ

  • Research Site

    Nottingham, NG5 1PB

  • Research Site

    Stevenage, SG1 4AB

Other trials in United Kingdom

Argentina5 sites

  • Research Site

    Buenos Aires, C1414AIF

  • Research Site

    Ciudad de Buenos Aire, C1121 ABE

  • Research Site

    La Plata, B1902COS

  • Research Site

    Mendoza, 5500

  • Research Site

    Mendoza, M5500GIP

Other trials in Argentina

Australia5 sites

  • Research Site

    Frankston, 3199

  • Research Site

    Nedlands, 6009

  • Research Site

    Parkville, 3050

  • Research Site

    Randwick, 2031

  • Research Site

    Woolloongabba, 4102

Other trials in Australia

Czechia4 sites

  • Research Site

    Karlovy Vary, 360 17

  • Research Site

    Pilsen, 304 60

  • Research Site

    Prague, 130 00

  • Research Site

    Rokycany, 337 22

Other trials in Czechia

Turkey (Türkiye)4 sites

  • Research Site

    Adana, 01330

  • Research Site

    Ankara, 06230

  • Research Site

    Bursa, 16059

  • Research Site

    Istanbul, 34098

Other trials in Turkey (Türkiye)

Chile3 sites

  • Research Site

    Quillota, 2260000

  • Research Site

    Talcahuano, 4270918

  • Research Site

    Valparaíso, 2341131

Other trials in Chile

About this study

Official title: A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).

Read the detailed description

This is an open-label safety extension study designed to evaluate the safety and tolerability of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order to protect the blind of BORA, patients will remain blinded to treatment regimen allocation until they have completed all end of treatment (EOT) assessments in BORA and signed informed consent for participation in this study, after which treatment allocation will be unblinded to both the investigator and the patient.

Conditions
Asthma
Being tested
Benralizumab
Keywords
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Medical subject headings
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenralizumabBiological

    Benralizumab administered subcutaneously every 4 weeks

  • BenralizumabBiological

    Benralizumab administered subcutaneously every 8 weeks

Study groups in NCT02808819
Study groupRoleWhat they receive
Benralizumab Arm AOtherBenralizumab administered subcutaneously every 4 weeks
Receives: Biological: Benralizumab
Benralizumab Arm BOtherBenralizumab administered subcutaneously every 8 weeks
Receives: Biological: Benralizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Basophils, Full Analysis Set

    Change from baseline in hematologic lab parameter of Basophils.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  2. Change From Baseline in Leukocytes, Full Analysis Set

    Change from baseline in hematologic lab parameter of Leukocytes.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  3. Change From Baseline in Lymphocytes, Full Analysis Set

    Change from baseline in hematologic lab parameter of Lymphocytes.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  4. Change From Baseline in Neutrophils, Full Analysis Set

    Change from baseline in hematologic lab parameter of Neutrophils.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  5. Change From Baseline in Monocytes, Full Analysis Set

    Change from baseline in hematologic lab parameter of Monocytes.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  6. Change From Baseline in Platelets, Full Analysis Set

    Change from baseline in hematologic lab parameter of Platelets.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  7. Change From Baseline in Hematocrit, Full Analysis Set

    Change from baseline in hematologic lab parameter of Hematocrit.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  8. Change From Baseline in Erythrocytes, Full Analysis Set

    Change from baseline in hematologic lab parameter of Erythrocytes.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  9. Change From Baseline in Hemoglobin, Full Analysis Set

    Change from baseline in hematologic lab parameter of Hemoglobin.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  10. Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set

    Change from baseline in chemistry test ALT.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  11. Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set

    Change from baseline in chemistry test AST.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  12. Change From Baseline in Bilirubin, Full Analysis Set

    Change from baseline in chemistry test Bilirubin.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Secondary outcomes (5)

  1. Number of Participants With Asthma Exacerbations During Study Period

    Asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit

    Measured: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.

  2. Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period

    Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma

    Measured: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.

  3. Change of Blood Eosinophils Count

    Change from Baseline to End of Treatment in blood eosinophils count.

    Measured: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

  4. Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study

    Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study

    Measured: From week 0 to week 184 in study treatment period and plus 12 weeks follow up period

  5. Duration of Exposure

    Duration of exposure

    Measured: From week 0 to week 184 in study treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion18 Jun 2020
  4. Study completion18 Jun 2020

Resources

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 3
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808819
Sponsor's protocol ID
D3250C00037
Acronym
MELTEMI
Status last verified
Mar 2021
First submitted
7 Jun 2016
Last updated
13 Apr 2021
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 178 sites in 15 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 5 inclusion and 16 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Poland, Germany, France, Ukraine and 10 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Apr 2021). 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?

Change From Baseline in Basophils, Full Analysis Set (time frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808819.

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 13 Apr 2021.

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