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

NCT02947945 | Unknown Phase 2 FDA Drug

• 1 other identifier: HS-3025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Reslizumab 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, reslizumab, 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)

• Document the safety of reslizumab therapy in patients with EGPA

  All adverse events will be reported to the sponsor and the IRB in accordance with the policy of National Jewish Health and the FDA. Adverse events will be recorded on Case Report Forms as non-serious or serious events (DAEs). Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the Serious Adverse Event form and faxed to the IRB and the sponsor as soon as site personnel are aware of the event. Every attempt will be made to collect discharge summaries for each hospitalization should they occur to provide further details.

  up to 12 months

Secondary Outcomes (1)

• Demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage

  up to 12 months

Study Arms (1)

Open-Label

OTHER

all subjects will receive the study medication- reslizumab.

Drug: Reslizumab

Interventions

Reslizumab DRUG

All subjects will receive Reslizumab

Also known as: Cinqair

Open-Label

Eligibility Criteria

• Age: 18 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 a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed IV CYC prior to visit 1, if their total WBC is ≥4x109/L prior to visit 1.
• 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 1.
• 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 1.

You may not qualify if:

• Hypereosinophilic Syndrome
• Wegener's Granulomatosis
• Malignancy
• Parasitic disease
• Pregnant or nursing
• 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.
• Any other medical illness that precludes study involvement
• Patients who are currently receiving or have previously received reslizumab or any other type of anti-interleukin therapy (i.e. mepolizumab, lebrikizumab etc.) within the last three months.
• Taking cyclophosphamide
• Any patients with a known hypersensitivity to reslizumab or any of its excipients

Sponsors & Collaborators

• National Jewish Health: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Related Publications (1)

• Manka LA, Guntur VP, Denson JL, Dunn RM, Dollin YT, Strand MJ, Wechsler ME. Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis. Ann Allergy Asthma Immunol. 2021 Jun;126(6):696-701.e1. doi: 10.1016/j.anai.2021.01.035. Epub 2021 Feb 4.

  PMID: 33548468 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

reslizumab

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

Central Study Contacts

Michael Wechsler, MD

CONTACT

303-398-1443; wechslerm@njhealth.org

Juno Pak

CONTACT

303-398-1132; pakj@njhealth.org

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: October 17, 2016
• First Posted: October 28, 2016
• Study Start: September 12, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)