Phase 2
Completed N=106
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
Source: ClinicalTrials.gov NCT00587288 ↗Enrolled (actual)
106
Serious AEs
2.8%
Results posted
Apr 2016
Primary outcomePrimary: Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score — -0.7; -0.3 units on a scale — p=0.0541
Summary
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score |
-0.7; -0.3 | 0.0541 |
| SECONDARY Percentage of ACQ Responders at End of Therapy |
55; 36; 45; 64 | 0.0848 |
| SECONDARY Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1) |
0.18; -0.08 | 0.0023 sig |
| SECONDARY Change From Baseline to End of Therapy in Percent Predicted FEV1 |
6.2; -2.4 | 0.0010 sig |
| SECONDARY Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels |
-82.0; 45.9 | 0.0068 sig |
| SECONDARY Percentage of Participants With Clinical Asthma Exacerbations (CAEs) |
8; 19 | 0.0833 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation |
38; 42; 3; 1; 12; 8 | — |
Eligibility Criteria
Inclusion Criteria
- written informed consent
- male or female subjects aged ≥ 18 to 75 years at time of screening
- female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
- confirmation of asthma
- symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
- requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
- requirement for >/= 3% eosinophils in induced sputum at Screening
Exclusion Criteria
- a clinically important event that would interfere with study schedule or procedure or compromise subject safety
- a diagnosis of hypereosinophilic syndrome
- an underlying lung disorder
- a current smoker
- use of systemic immunosuppressive agents within 6 months of study
- current use of systemic corticosteroids
- received attenuated live attenuated vaccines within three months prior to study entry
- expected to be poorly compliant with study drug, procedures, visits
- aggravating factors that are inadequately controlled
- participation in any investigational drug or device study within 30 days prior to study entry
- participation in biologics study within 3 months prior to study entry
- receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
- female subjects who are pregnant or nursing
- concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
- concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
- current suspected drug and/or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT00587288). 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.