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Monoclonal Antibodies

Increased Reslizumab Dosage for Severe Asthma

Phase 4

Waitlist Available

Led By Parameswaran Nair, MD, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial found that increasing the dose of reslizumab can help to reduce sputum eosinophilia in people with severe asthma who continue to have this problem despite treatment with reslizumab at the standard dose.

Who is the study for?

This trial is for adults with severe asthma confirmed in the last 2 years, who are already on high-dose inhaled corticosteroids and long-acting beta agonists. Participants must have a certain level of eosinophils (a type of white blood cell) in their blood or sputum. Smokers, recent ex-smokers, drug/alcohol abusers, those on immunosuppressants or other biologics (except denosumab), and individuals with significant other diseases cannot participate.

What is being tested?

The study tests if increasing the dose of Reslizumab can better control eosinophilia (high levels of eosinophils) in the sputum of patients with severe asthma who don't respond to standard doses. It's seeing whether more medicine can help when less doesn't work.

What are the potential side effects?

Reslizumab may cause side effects such as allergic reactions at the infusion site, muscle pain, fatigue, and potentially worsen pre-existing conditions. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sputum eosinophilia

Secondary study objectives

Change in ACQ5 score

Change in Blood eosinophil count

Change in Cumulative systemic corticosteroid dose

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Active Control

Group I: Reslizumab 3 mg/kgActive Control1 Intervention

All patients will initially receive reslizumab 3 mg/kg for at least 16 weeks.

Group II: Reslizumab 4 mg/kgActive Control1 Intervention

Patients who have uncontrolled sputum eosinophilia at 16 weeks will receive an increased dose of 4 mg/kg for the next 16 weeks. The patients with controlled eosinophilia will continue to receive 3 mg/kg.

Group III: Reslizumab 5 mg/kgActive Control1 Intervention

Patients who have uncontrolled sputum eosinophilia who were previously receiving reslizumab at 4 mg/kg at 32 weeks will receive an increased dose of 5 mg/kg for the next 16 weeks. The patients remaining patients will continue on the dose they were receiving (i.e., either 3 mg/kg or 4 mg/kg).

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