Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

Study Purpose

This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female subjects age 18 years or older. 2. EGPA diagnosis based on history or presence asthma and eosinophilia (>1.0x10^9/L and/or >10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3). 3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and > 12 weeks prior to screening, or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose <=7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of ≥7.5 mg/day prednisolone or equivalent. If induction with glucocorticoidsalone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be ≥15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization. 4. Must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not >50mg/day) for at least 4 weeks prior to randomization. Stable doses of OCS other than prednisolone or prednisone may be acceptable, but must be discussed with the AstraZeneca study physician. 5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted). 6. QTc(F)<450 msec or QTc(F)<480 msec for patients with bundle branch block. 7. Females of childbearing potential must use an acceptable method of birth control from signing the informed consent for at least 12 weeks after the last study drug administration.

Exclusion Criteria:

1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). 2. Organ or life-threatening EGPA < 3 months prior to screening and through randomisation. 3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation. 4. Current malignancy or history of malignancy, unless received curative therapy >5 years ago, or >1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. 5. An untreated or refractory helminth parasitic infection < 24 weeks prior to screening. 6. Unstable liver disease. 7. Severe or clinically significant, uncontrolled cardiovascular disease. 8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study. 9. Chronic or ongoing infectious disease requiring systemic antiinfective treatment. 10. Known immunodeficiency disorder or positive HIV test. 11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-α or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening, receipt of of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer . Or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to screening (V1), whichever is longer, prior to screening.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04157348
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Wechsler, MD
Principal Investigator Affiliation National Jewish Health, 1400 Jackson St Denver, CO 80206
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, France, Germany, Israel, Italy, Japan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Granulomatous Vasculitis
Arms & Interventions

Arms

Experimental: Benralizumab arm

1x benralizumab SC injection + 3x placebo to mepolizumab SC injections

Active Comparator: Mepolizumab arm

3x mepolizumab SC injections + 1x placebo to benralizumab SC injection

Interventions

Biological: - Benralizumab

30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)

Biological: - Mepolizumab

3x100 mg vials of powder for solution for injection reconstituted into 3 separate 1 mL syringes for administration on each dosing occasion. Injection volume per syringe is 1 mL. Mepolizumab active solution will be administered subcutaneously (SC)

Biological: - Placebo to Mepolizumab

Matching placebo: 0.9% sodium chloride, solutions for injection in 1mL syringes (3 syringes will be used on each dosing occasion). Injection volume per syringe is 1mL. Placebo to Mepolizumban will be administered subcutaneously (SC)

Biological: - Placebo to Benralizumab

Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, La Jolla, California

Status

Suspended

Address

Research Site

La Jolla, California, 92093

Research Site, Denver, Colorado

Status

Recruiting

Address

Research Site

Denver, Colorado, 80206

Research Site, New Haven, Connecticut

Status

Suspended

Address

Research Site

New Haven, Connecticut, 06510

Research Site, Jacksonville, Florida

Status

Suspended

Address

Research Site

Jacksonville, Florida, 32224

Research Site, Atlanta, Georgia

Status

Suspended

Address

Research Site

Atlanta, Georgia, 30322

Research Site, Kansas City, Kansas

Status

Not yet recruiting

Address

Research Site

Kansas City, Kansas, 66160

Research Site, Lexington, Kentucky

Status

Suspended

Address

Research Site

Lexington, Kentucky, 40502

Research Site, Boston, Massachusetts

Status

Suspended

Address

Research Site

Boston, Massachusetts, 02215

Research Site, Ann Arbor, Michigan

Status

Recruiting

Address

Research Site

Ann Arbor, Michigan, 48109

Research Site, Rochester, Minnesota

Status

Not yet recruiting

Address

Research Site

Rochester, Minnesota, 55905-0001

Research Site, Albuquerque, New Mexico

Status

Suspended

Address

Research Site

Albuquerque, New Mexico, 87131

Research Site, Great Neck, New York

Status

Suspended

Address

Research Site

Great Neck, New York, 11021

Research Site, New York, New York

Status

Suspended

Address

Research Site

New York, New York, 10021

Research Site, Chapel Hill, North Carolina

Status

Suspended

Address

Research Site

Chapel Hill, North Carolina, 27599

Research Site, Cleveland, Ohio

Status

Suspended

Address

Research Site

Cleveland, Ohio, 44195

Research Site, Columbus, Ohio

Status

Suspended

Address

Research Site

Columbus, Ohio, 43210

Research Site, Oklahoma City, Oklahoma

Status

Suspended

Address

Research Site

Oklahoma City, Oklahoma, 73104

Research Site, Portland, Oregon

Status

Suspended

Address

Research Site

Portland, Oregon, 97239

Research Site, Philadelphia, Pennsylvania

Status

Suspended

Address

Research Site

Philadelphia, Pennsylvania, 19104

Research Site, Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

Research Site

Pittsburgh, Pennsylvania, 15261

Research Site, Nashville, Tennessee

Status

Suspended

Address

Research Site

Nashville, Tennessee, 37232

Research Site, Denison, Texas

Status

Suspended

Address

Research Site

Denison, Texas, 75020

Research Site, Salt Lake City, Utah

Status

Not yet recruiting

Address

Research Site

Salt Lake City, Utah, 84132

Research Site, Norfolk, Virginia

Status

Suspended

Address

Research Site

Norfolk, Virginia, 23507

Research Site, Richmond, Virginia

Status

Suspended

Address

Research Site

Richmond, Virginia, 23298

Research Site, Seattle, Washington

Status

Suspended

Address

Research Site

Seattle, Washington, 98115

Research Site, Spokane, Washington

Status

Suspended

Address

Research Site

Spokane, Washington, 99204

International Sites

Research Site, Brussels, Belgium

Status

Not yet recruiting

Address

Research Site

Brussels, , 1070

Research Site, Brussel, Belgium

Status

Not yet recruiting

Address

Research Site

Brussel, , 1090

Research Site, Calgary, Alberta, Canada

Status

Suspended

Address

Research Site

Calgary, Alberta, T2N 4Z6

Research Site, Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

Research Site

Hamilton, Ontario, L8N 4A6

Research Site, Toronto, Ontario, Canada

Status

Suspended

Address

Research Site

Toronto, Ontario, M5G 1E2

Research Site, Toronto, Ontario, Canada

Status

Suspended

Address

Research Site

Toronto, Ontario, M5T 3A9

Research Site, Dijon Cedex, France

Status

Not yet recruiting

Address

Research Site

Dijon Cedex, , 21034

Research Site, Lille Cedex, France

Status

Not yet recruiting

Address

Research Site

Lille Cedex, , 59037

Research Site, Marseille, France

Status

Not yet recruiting

Address

Research Site

Marseille, , 13915

Research Site, Montpellier, France

Status

Not yet recruiting

Address

Research Site

Montpellier, , 34295

Research Site, Nantes Cedex 1, France

Status

Not yet recruiting

Address

Research Site

Nantes Cedex 1, , 44093

Research Site, Paris, France

Status

Not yet recruiting

Address

Research Site

Paris, , 75014

Research Site, Paris, France

Status

Recruiting

Address

Research Site

Paris, , 75018

Research Site, Suresnes Cedex, France

Status

Not yet recruiting

Address

Research Site

Suresnes Cedex, , 92151

Research Site, Toulouse, France

Status

Not yet recruiting

Address

Research Site

Toulouse, , 31059

Research Site, Bamberg, Germany

Status

Recruiting

Address

Research Site

Bamberg, , 96049

Research Site, Freiburg, Germany

Status

Not yet recruiting

Address

Research Site

Freiburg, , 79106

Research Site, Hamburg, Germany

Status

Suspended

Address

Research Site

Hamburg, , 20251

Research Site, Jena, Germany

Status

Not yet recruiting

Address

Research Site

Jena, , 07747

Research Site, Kirchheim, Germany

Status

Recruiting

Address

Research Site

Kirchheim, , 73230

Research Site, Lübeck, Germany

Status

Not yet recruiting

Address

Research Site

Lübeck, , 23538

Research Site, München, Germany

Status

Not yet recruiting

Address

Research Site

München, , 80336

Research Site, Ashkelon, Israel

Status

Recruiting

Address

Research Site

Ashkelon, , 7830604

Research Site, Beer Sheva, Israel

Status

Recruiting

Address

Research Site

Beer Sheva, , 84101

Research Site, Jerusalem, Israel

Status

Suspended

Address

Research Site

Jerusalem, , 91120

Research Site, Ramat Gan, Israel

Status

Recruiting

Address

Research Site

Ramat Gan, ,

Research Site, Rehovot, Israel

Status

Recruiting

Address

Research Site

Rehovot, , 7661041

Research Site, Tel Aviv, Israel

Status

Recruiting

Address

Research Site

Tel Aviv, , 6423906

Research Site, Cuneo, Italy

Status

Not yet recruiting

Address

Research Site

Cuneo, , 12100

Research Site, Firenze, Italy

Status

Not yet recruiting

Address

Research Site

Firenze, , 50141

Research Site, Milano, Italy

Status

Not yet recruiting

Address

Research Site

Milano, , 20132

Research Site, Milano, Italy

Status

Not yet recruiting

Address

Research Site

Milano, , 20162

Research Site, Napoli, Italy

Status

Not yet recruiting

Address

Research Site

Napoli, , 80131

Research Site, Roma, Italy

Status

Not yet recruiting

Address

Research Site

Roma, , 00168

Research Site, Verona, Italy

Status

Not yet recruiting

Address

Research Site

Verona, , 37134

Research Site, Chiba-shi, Japan

Status

Recruiting

Address

Research Site

Chiba-shi, , 260-0877

Research Site, Sagamihara-shi, Japan

Status

Recruiting

Address

Research Site

Sagamihara-shi, , 228-0815

Research Site, Sendai-shi, Japan

Status

Recruiting

Address

Research Site

Sendai-shi, , 980-8574

Research Site, Shinjuku-ku, Japan

Status

Not yet recruiting

Address

Research Site

Shinjuku-ku, , 162-8666

Research Site, Cambridge, United Kingdom

Status

Suspended

Address

Research Site

Cambridge, , CB2 0QQ

Research Site, Leicester, United Kingdom

Status

Suspended

Address

Research Site

Leicester, , LE3 9QP

Research Site, London, United Kingdom

Status

Recruiting

Address

Research Site

London, , SE19RT

Research Site, London, United Kingdom

Status

Suspended

Address

Research Site

London, , W12 0HS

Research Site, Portsmouth, United Kingdom

Status

Recruiting

Address

Research Site

Portsmouth, , PO6 3LY

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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