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AsthmaPhase 2BITENCT03010436

Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

A Phase 2 study testing Benralizumab in people with Asthma, run by National Jewish Health at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Benralizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. Read more about this study

Who is it for?
Ages 18 to 100 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
10 participants
Where
1 siteUnited States
Study dates
15 Apr 2017to Dec 2021
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
  • Gender and Age: Male or female subjects >18 years old
  • EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia (>1.0x109/L and/or >10% of leucocytes) plus at least two of the following additional features of EGPA
  • A biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation;
  • Neuropathy, mono or poly (motor deficit or nerve conduction abnormality);
  • Pulmonary infiltrates, non-fixed;
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  • Sino-nasal abnormality;
  • Cardiomyopathy (established by echocardiography or MRI);
  • Glomerulonephritis (haematuria, red cell casts, proteinuria);
  • Alveolar haemorrhage (by bronchoalveolar lavage);
  • Palpable purpura;
  • ANCA positive (MPO or PR3).
  • Subjects who have received cyclophosphamide can be included after a 4-week washout prior to visit 0 (first injection).
  • Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to visit 0.
  • Corticosteroid therapy: Subject must be on a stable dose of oral prednisolone or prednisone of ≥5 mg/day for at least 4 weeks prior to visit 0.
  • Immunosuppressive therapy: If receiving immunosuppressive therapy (including methotrexate, azathioprine, or mycophenolate mofetil, but excluding restricted medications below) the dosage must be stable for the 4 weeks prior to visit 0 and during the study (dose reductions for safety reasons will be permitted).
  • Female subjects: Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD intrauterine device/IUS levonogestrel Intrauterine system, Depo-Provera(tm) injections, oral contraceptive, and Evra Patch(tm) or Nuvaring(tm). WOCBP must agree to use effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks after last dose of IP, and have negative serum pregnancy test result on Visit 0.
  • Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of visit -1 without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
  • Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
  • All male subjects who are sexually active must agree to use an acceptable method of contraception (condom with or without spermicide, vasectomy) from Visit 0 until 16 weeks after their last dose.

Who cannot join

  • Hypereosinophilic Syndrome
  • Wegener's Granulomatosis
  • History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent when applicable was obtained. Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date informed consent, and assent when applicable, was obtained.
  • A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
  • Pregnant or nursing
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period.
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  • If female and of child-bearing potential, must have negative pregnancy test and must adhere to acceptable method of contraception (with <1% failure rate) during the study and for four months after the study.
  • Receipt of any investigational non biologic within 30 days or 5 half-lives prior to visit 0, whichever is longer.
  • A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
  • Any other medical illness that precludes study involvement
  • Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, 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 be enrolled.
  • Patients who are currently receiving or have previously received benralizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, reslizumab, lebrikizumab etc.) within the last 4 months or 5 half-lives whichever is longer.
  • History of anaphylaxis to any biologic therapy or vaccine.
  • Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
  • Taking cyclophosphamide

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Jewish Health

    Denver, Colorado, 80206

Other trials in United States

About this study

Official title: The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE

Benralizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, benralizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

Read the detailed description

This study is open-label which means that all subjects will receive the study medication. The medicine-benralizumab-will be given to subjects in addition to the medicines they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and medicines that reduce the activity of their immune system. Drugs that are sometimes used (i.e., standard of care) to reduce the activity of the immune system in EGPA (in addition to oral steroids) include azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how the stud drug that you get affects the subjects body and their health will be collected through a number of tests, procedures and questions.

The study medicine, benralizumab, will be given to subjects as one injection 30 mg under skin every four weeks for 12 weeks and then every 8 weeks for 16 weeks for a total of 5 treatments. During the treatment phase of this study, a study staff member will call the subjects to see how they are doing, what medications they are taking and if they are able to decrease their steroid use. The study is a total of 9 study visits in a 44 week time period. Everyone who takes part in the study will continue to receive his/her existing treatments for EGPA (although their dose of oral steroids may be reduced during the study.

Conditions
Asthma
Being tested
Benralizumab
Medical subject headings
Asthma

What participants receive

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

  • BenralizumabDrug

    one injection 30 mg under the subjects skin every 4 weeks for 8 weeks and then every 8 weeks for 24 weeks for a total of 5 treatments.

Study groups in NCT03010436
Study groupRoleWhat they receive
Open-LabelOtherAll subjects will receive the study medication- benralizumab
Receives: Drug: Benralizumab

What is being measured

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

  1. All adverse events will be reported by count of events (safety and tolerability )

    All adverse events will be reported to AstraZeneca and the IRB in accordance with the policy of National Jewish Health and the FDA. Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the SAE event form will be sent to AstraZeneca within 24 hours of submission to the FDA.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Change in corticosteroid dosage

    Change in steroid dose will be assessed by comparing the corticosteroid dose to subjects at the end of the steroid stable phase and compare to steroid dose at the end of treatment period.

    Measured: Up to 12 months

  2. Change in the rate of EGPA exacerbations during the study period.

    Change in the rate of exacerbations will be assessed by comparing the rate of exacerbations during the study period with the rate during the washout and safety-monitoring period as well as with the self-reported rate of exacerbations from the year prior to the study.

    Measured: Up to 12 months

Timeline

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

  1. First posted5 Jan 2017 (estimated)
  2. Study start15 Apr 2017
  3. Primary completion25 Jul 2019
  4. Study completionDec 2021 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03010436
Sponsor's protocol ID
HS-3010
Acronym
BITE
Status last verified
Mar 2021
First submitted
11 Dec 2016
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee Y, Hojjati M. Benralizumab as a Potential Adjunctive Therapy in Eosinophilic Granulomatosis With Polyangiitis. J Clin Rheumatol. 2021 Dec 1;27(8S):S401-S402. doi: 10.1097/RHU.0000000000001419. No abstract available.

    PubMed 32453217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Benralizumab in people with Asthma, run by National Jewish Health at 1 site 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 21 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

All adverse events will be reported by count of events (safety and tolerability ) (time frame: Up to 12 months). 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 NCT03010436, which also lists 1 linked publication.

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 8 Mar 2021.

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