Phase 3
Completed N=177
An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
Asthma · Elevated Blood Eosinophils · Oral Corticosteroid Dependence
Source: ClinicalTrials.gov NCT02501629 ↗
Enrolled (actual)
177
Serious AEs
7.9%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline — 20; 18; 4; 8 Participants — p=0.468
◆ Published Evidence
Established
23citations · ~4 / year
Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials.
Summary
The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.
Linked Publications
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Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline |
20; 18; 4; 8; 8; 13 | 0.468 |
| SECONDARY Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control |
36; 44; 64; 56 | 0.234 |
| SECONDARY Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control |
38; 42; 62; 58 | 0.596 |
| SECONDARY Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures |
-40.34; -58.08 | 0.101 |
| SECONDARY Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control |
35; 41; 65; 59 | 0.341 |
| SECONDARY Annualized Rate of Clinical Asthma Exacerbations (CAEs) |
1.86; 1.51 | 0.407 |
| SECONDARY Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control |
22; 20; 78; 80 | 0.628 |
| SECONDARY Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses |
0; 11; 0; 0 | — |
| SECONDARY Participants With Adverse Events |
47; 57; 3; 7; 4; 10 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
- Written informed consent is obtained.
- The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
- The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
- The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
- The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
- Other criteria may apply, please contact the investigator for more information.
Exclusion Criteria
- The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
- The patient has another confounding underlying lung disorder.
- The patient has a known hypereosinophilic syndrome.
- The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- The patient is pregnant or intends to become pregnant during the study or is lactating.
- The patient required treatment for an asthma exacerbation within 4 weeks of screening.
- The patient is a current smoker or has a smoking history ≥10 pack-years.
- The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
- The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- The patient was previously exposed to benralizumab within 12 months of screening.
- The patient was previously exposed to reslizumab.
- The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
- The patient has current suspected drug and/or alcohol abuse.
- The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
- The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
- Other criteria may apply, please contact the investigator for more information.
Data sourced from ClinicalTrials.gov (NCT02501629) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.