Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".

NCT04585997 | Unknown Phase 4

• 1 other identifier: 18/08/15/3.01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) used in the treatment of severe allergic eosinophilic asthma The investigators propose that in patients with the dual phenotypes of severe allergic and eosinophilic asthma, that Mepolizumab is as effective as Omalizumab. However, this trial will also identify key clinical biomarkers that will clarify which patients will respond best to each of these interventions. This study will be the first direct clinical comparison of these agents and will apply expert clinical characterization, along with cutting edge biotechnology to better inform treatment choices for severe asthma. This is an important and urgent management problem facing the Australian pharmaceutical scheme, where imprecision in prescribing will result in reduced clinical effectiveness as well as substantial and sustained costs.

Conditions

Asthma; Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• ACQ5

  The primary outcome will be Asthma control questionairre (ACQ)5, adjusted for baseline ACQ5

  Assessed after 6 months treatment

Secondary Outcomes (10)

• Exacerbations

  every month up to 6 months after treatment commenced

• Time to first exacerbation reported, by patient or health provider

  every month up to 6 months after treatment commenced

• Hospital admissions

  every month up to 6 months after treatment commenced

• Oral corticosteroids

  every month up to 6 months after treatment commenced

• Spirometry

  every month up to 6 months after treatment commenced

Study Arms (2)

Mepolizumab

ACTIVE COMPARATOR

Mepolizumab

Drug: Mepolizumab

Omalizumab

ACTIVE COMPARATOR

Omalizumab

Drug: Omalizumab

Interventions

Mepolizumab DRUG

Mepolizumab 100mg subcutaneous injection monthly for 6 months

Also known as: Nucala

Mepolizumab

Omalizumab DRUG

Omalizumab subcutaneous injection every 2-4 weeks (dosage determined by the Omalizumab nomogram).

Also known as: Xolair

Omalizumab

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a duration of asthma of greater than one year.
• They must have confirmed asthma defined as: (i) forced expiratory volume (FEV1) reversibility greater than or equal to 12%, and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), or (ii) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, or (iii) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days.
• They must have evidence of poor asthma control despite optimal ICS and long acting beta agonist (LABA), be treated by a respiratory physician or immunologist, and have demonstrated acceptable adherence and inhaler technique. Poor control is defined as: evidence of an FEV1 \<80% of predicted in the last year on at least one occasion; treatment with OCS, either daily for at least 6 weeks, or a cumulative dose of OCS of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.
• In addition they must demonstrate an: (a) an Asthma Control Questionnaire (ACQ-5)38 score of at least 2.0, as assessed in the previous month, and (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, or 1 severe asthma exacerbation, requiring documented use of OCS initiated or increased for at least 3 days, or parenteral corticosteroids prescribed/supervised by a physician.
• They must also demonstrate evidence of a dual allergic/ eosinophilic phenotype. This is defined as: a total serum IgE \>30IU/mL, past or current evidence of atopy documented by skin prick testing or radioallergosorbent assay, and the participant must have a blood eosinophil count greater than or equal to 300 cells per microlitre in the last 6 weeks.

You may not qualify if:

• Unable to attend appointments
• Significant psychiatric illness

Sponsors & Collaborators

• University of Newcastle, Australia: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

mepolizumab; Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Peter Wark, MBBS/PhD

  University of Newcastle and Hunter New England Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Wark, MBBS/PhD

CONTACT

(02) 40420110; peter.wark@health.nsw.gov.au

Gerard Kaiko, PhD

CONTACT

(02) 40420184; gerard.kaiko@newcastle.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: People assessing outcomes and analyzing results are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Staff Respiratory Specialist

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: November 3, 2018
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AU (1)