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

NCT03010436 | Unknown Phase 2 FDA Drug

• 1 other identifier: HS-3010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. It is considered an experimental drug in this study.

Conditions

Asthma

Outcome Measures

Primary Outcomes (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.

  Up to 12 months

Secondary Outcomes (2)

• Change in corticosteroid dosage

  Up to 12 months

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

  Up to 12 months

Study Arms (1)

Open-Label

OTHER

All subjects will receive the study medication- benralizumab

Drug: Benralizumab

Interventions

Benralizumab DRUG

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.

Open-Label

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Jewish Health: lead
• AstraZeneca: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• 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.

  PMID: 32453217 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael Wechsler, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: January 5, 2017
• Study Start: April 15, 2017
• Primary Completion: July 25, 2019
• Study Completion: December 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)