Phase 3
N=468
Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02452190 ↗Enrolled (actual)
468
Serious AEs
8.1%
Results posted
Feb 2019
Primary outcome: Primary: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment — 0.52; 0.41 events — p=0.194
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Reslizumab (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment |
0.52; 0.41 | 0.194 |
| SECONDARY Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
0.225; 0.368 | — |
| SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score |
1.06; 1.14 | — |
| SECONDARY Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score |
-1.14; -1.22 | — |
| SECONDARY Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night) |
-1.4; -1.5 | — |
| SECONDARY Percentage of Asthma Control Days |
7.1; 8.0 | — |
| SECONDARY Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score |
-13.1; -16.4 | — |
| SECONDARY Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52 |
0.66; 0.66 | — |
| SECONDARY Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment |
0.05; 0.05 | — |
| SECONDARY Number of Moderate Exacerbations During 52 Weeks of Treatment |
0.15; 0.14 | — |
Summary
The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.
Eligibility Criteria
Inclusion Criteria
- Written informed consent is obtained.
- The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
- The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
- The participant has required an inhaled corticosteroid.
- The participant has required an additional asthma controller medication besides inhaled corticosteroids.
- The participant has a history of asthma exacerbation.
- The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- Additional criteria may apply, please contact the investigator for more information
Exclusion Criteria
- The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
- The participant has another confounding underlying lung disorder
- The participant has a known hypereosinophilic syndrome.
- The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
- The participant is a current smoker or has a smoking history.
- The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- The participant was previously exposed to reslizumab.
- The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
- The participant has current or suspected drug and alcohol abuse.
- The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
- The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.
- Additional criteria may apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT02452190). 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.