Clinical Trial Results:
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
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Summary
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EudraCT number |
2016-004661-23 |
Trial protocol |
BE HU CZ DE FR ES PL RO |
Global end of trial date |
22 Feb 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jan 2019
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First version publication date |
06 Jan 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C38072-AS-30066
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03052725 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Teva Branded Pharmaceutical Products, R&D Inc.
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Sponsor organisation address |
41 Moores Road, Frazer, PA, United States, 19355
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Public contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 888-483-8279, info.era-clinical@teva.de
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Scientific contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 888-483-8279, info.era-clinical@teva.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jul 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Feb 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to support the long-term safety of reslizumab 110 mg administered sc once every 4 weeks in patients 12 years of age and older with severe eosinophilic asthma that was inadequately controlled on standard-of-care treatment.
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Protection of trial subjects |
This study was conducted in full accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (eg, Code of Federal Regulations [CFR] Title 21, Parts 11, 50, 54, 56, 312, and 314; European Union Directive 2001/20/EC on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical trials on medicinal products for human use). The principal investigator at each study center was responsible for the conduct and administration of the study at that center and for contacts with study center management, with the IEC/IRB, and with local authorities. Written and/or oral information about the study was provided to all patients in nontechnical language understandable by the patients. The information included an adequate explanation of the aims, methods, anticipated benefits, potential hazards, and insurance arrangements in force. Written informed consent was obtained from each patient before any study procedures or assessments were done. It was explained to the patients that they were free to refuse entry into the study and free to withdraw from the study at any time without prejudice to future treatment. For patients aged 12 to <18 years, a signed and dated informed consent form was obtained from a parent/legally acceptable representative, and a signed and dated assent form was obtained from each patient before any study-specific procedures or assessments were done and after the aims, methods, anticipated benefits, and potential hazards were explained, according to local IRB/IEC requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 19
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Country: Number of subjects enrolled |
Canada: 4
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Country: Number of subjects enrolled |
Czech Republic: 17
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Country: Number of subjects enrolled |
Germany: 31
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Country: Number of subjects enrolled |
Spain: 3
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Country: Number of subjects enrolled |
France: 4
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Country: Number of subjects enrolled |
Hungary: 26
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Country: Number of subjects enrolled |
Israel: 36
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Country: Number of subjects enrolled |
Poland: 19
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Country: Number of subjects enrolled |
Romania: 11
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Country: Number of subjects enrolled |
Russian Federation: 33
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Country: Number of subjects enrolled |
Ukraine: 104
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Country: Number of subjects enrolled |
United States: 84
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Worldwide total number of subjects |
391
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EEA total number of subjects |
130
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
17
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Adults (18-64 years) |
296
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From 65 to 84 years |
78
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 392 patients with severe eosinophilic asthma rolled over from Study 30025 or 30027, and 391 of these patients (at 125 centers) were enrolled into this extension study and treated with reslizumab. One patient withdrew consent after completing Study 30025 and before enrolling in Study 30066. | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Of the 391 patients enrolled, 112 (29%) enrolled seamlessly and 279 (71%) enrolled non-seamlessly, meaning there was a time gap between completion of the parent study and start of this extension study. | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Reslizumab 110 mg; Previous Treatment Placebo | ||||||||||||||||||||||||||||||
Arm description |
Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Reslizumab
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Investigational medicinal product code |
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Other name |
CINQAIR®
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Reslizumab was administered as 110 mg subcutaneous (sc) injections in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.
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Arm title
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Reslizumab 110 mg: Previous Treatment Reslizumab | ||||||||||||||||||||||||||||||
Arm description |
Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Reslizumab
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Investigational medicinal product code |
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Other name |
CINQAIR®
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Reslizumab was administered as 110 mg subcutaneous (sc) injections in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.
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Baseline characteristics reporting groups
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Reporting group title |
Reslizumab 110 mg; Previous Treatment Placebo
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Reporting group description |
Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Reslizumab 110 mg: Previous Treatment Reslizumab
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Reporting group description |
Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Reslizumab 110 mg; Previous Treatment Placebo
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Reporting group description |
Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||
Reporting group title |
Reslizumab 110 mg: Previous Treatment Reslizumab
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Reporting group description |
Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||
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End point title |
Participants With Treatment-Emergent Adverse Events (TEAEs) [1] | |||||||||||||||||||||||||||
End point description |
An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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End point type |
Primary
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End point timeframe |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No intention to make inference based on stat analysis; the intent is to support clinical judgment. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Participants With Potentially Clinically Significant Abnormal Hematology Values | |||||||||||||||||||||||||||||||||
End point description |
Participants are included in the counts if the worst study value reaches the following clinically significant levels: Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values | |||||||||||||||||||||||||||||||||
End point description |
Participants are included in the counts if the worst study value reaches the following clinically significant levels: Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Participants’ Tolerability and Injection Site Reactions by Domain and Worst Overall Severity | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration. Severity was rated on a 4-level scale of none, mild, moderate and severe.
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End point type |
Secondary
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End point timeframe |
Weeks 4, 8, 12, 16, 20, 24, 28, and 36
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Participants with Potentially Clinically Significant Abnormal Vital Sign Values | ||||||||||||||||||||||||||||||
End point description |
Participants are included in the counts if the worst study value reaches the following clinically significant levels: Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Annualized Rate of Clinical Asthma Exacerbations (CAEs) | ||||||||||||
End point description |
Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.
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End point type |
Secondary
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End point timeframe |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits | ||||||||||||
End point description |
Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.
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End point type |
Secondary
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End point timeframe |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean Number of Days of Hospital Stay During the Treatment Period | ||||||||||||
End point description |
Participants with no hospitalizations are included.
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End point type |
Secondary
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End point timeframe |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period | ||||||||||||
End point description |
Participants with no school or work days missed due to asthma are included in the counts.
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End point type |
Secondary
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End point timeframe |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change from Baseline Values at Weeks 8, 24 and 36 | ||||||||||||||||||||||||
End point description |
The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters. Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 8, 24, 36
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change from Baseline Values at Weeks 1, 4, 8, 24 and 36 | ||||||||||||||||||||||||||||||
End point description |
A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 1, 4, 8, 24, 36
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Percent Change from Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36 | ||||||||||||||||||
End point description |
Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose. Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range. Percent change = 100 * (absolute change / baseline dose)
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End point type |
Secondary
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End point timeframe |
Week 0 (baseline), Weeks 16-20, Weeks 32-36
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change from Baseline Values at Weeks 1, 4, 8, 24 and 36 | ||||||||||||||||||||||||||||||
End point description |
Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages. The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1, 4, 8, 24, 36
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change from Baseline Values at Weeks 8, 24 and 36 | ||||||||||||||||||||||||
End point description |
The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Negative change from baseline values indicate improved asthma control.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 8, 24, 36
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 years (AQLQ +12) Overall Score: Baseline Values and Change from Baseline Values at Weeks 8, 24 and 36 | ||||||||||||||||||||||||
End point description |
The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Positive change from baseline values indicate improved quality of life.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 8, 24, 36
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Participants with Treatment-Emergent Anti-Drug Antibody (ADA) Responses | |||||||||
End point description |
Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample. Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb). The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.
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End point type |
Secondary
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End point timeframe |
Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal
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| No statistical analyses for this end point | ||||||||||
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End point title |
Participants with Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51) | |||||||||
End point description |
The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.
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End point type |
Secondary
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End point timeframe |
Week 51
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| Notes [2] - Due to early termination, no participants had an end of study visit. [3] - Due to early termination, no participants had an end of study visit. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Reslizumab 110 mg
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Reporting group description |
Participants were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
