Clinical Trial Results:
An Open-Label Safety Study of Patients with Severe Eosinophilic Asthma Who Were Previously Enrolled in the Reslizumab Open Label Extension Study C38072/3085
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Summary
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EudraCT number |
2014-002659-25 |
Trial protocol |
FR |
Global end of trial date |
06 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Oct 2018
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First version publication date |
21 Oct 2018
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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-30024
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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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, Pennsylvania, United States, 19355
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Public contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., 1 888-483-8279, info.era-clinical@teva.de
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Scientific contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., 1 888-483-8279, 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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Mar 2017
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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 |
06 Mar 2017
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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 open-label study is to obtain additional long-term safety data for reslizumab in patients with eosinophilic asthma who enrolled in open-label extension study C38072/3085. These data include adverse events, vital signs, and concomitant medications.
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Protection of trial subjects |
This study was conducted in full accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (eg, EU Directive 2001/20/EC on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use).
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
26 Nov 2014
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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 |
France: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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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) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
Eligible patients must have completed the Study C38072/3085 end-of-treatment visit or early termination visit. In all cases, the screening/baseline visit must have been scheduled at least 21 days after the subject’s last dose of reslizumab in the previous 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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Arm title
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Reslizumab | ||||||
Arm description |
Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
reslizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The reslizumab dose was calculated based on baseline body weight.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
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End points reporting groups
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Reporting group title |
Reslizumab
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Reporting group description |
Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks. | ||
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End point title |
Number of Subjects wth Treatment Emergents Adverse Events (AEs) and Serious AEs (SAEs) [1] | ||||||||||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it had a causal relationship with this treatment. An SAE was defined as an AE occurring at any dose that resulted in any of the following outcomes or actions: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; a congenital anomaly or birth defect; an important medical event that may have resulted in death, was not life-threatening, or did not require hospitalization, but may have jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs summarized are those that began or worsened after treatment with reslizumab.
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End point type |
Primary
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End point timeframe |
Day 1 up to Day 757.
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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: There is no analysis because the study has a single arm |
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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 |
Rate of yearly asthma exacerbation is defined as number of exacerbations/(duration of treatment phase (days)/365.25).
CAEs were recorded on the electronic case report form. A worsening of asthma was recorded in the adverse event electronic case report form (eCRF) as a clinical asthma exacerbation if it met 1 or more of the following criteria:
1. use of systemic corticosteroids (or at least a doubling of the maintenance dose of systemic corticosteroids) for 3 days or more,
2. an emergency department visit because of asthma that required systemic corticosteroids for 3 days or more, or
3. hospitalization because of asthma.
Additional adverse events other than “clinical asthma exacerbations” that were reported by the investigator as associated to asthma and had a concomitant requirement for a systemic corticosteroid or resulted in hospitalization were adjudicated as asthma exacerbation and were also counted, if applicable.
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End point type |
Secondary
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End point timeframe |
Day 1 up to Day 757.
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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 up to Day 757.
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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 |
18.0
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Reporting groups
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Reporting group title |
Reslizumab
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Reporting group description |
Reslizumab (3.0 mg/kg), administered by intravenous (IV) infusion every 4 weeks (28 days±7 days) for up to 104 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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30 Jul 2014 |
The following major procedural changes were made to the protocol: - change to the planned study period in response to a request from the investigator - changes to the stopping rules and discontinuation in response to a request from the investigator |
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05 Sep 2016 |
The following major procedural changes were made to the protocol: - update in information on reslizumab safety, including relevant clinical results and risk/benefit assessment included in the updated Investigator’s Brochure - extension of the observation period after reslizumab injection from at least 30 minutes to at least 60 minutes after the final saline flush - clarification that birth control should be used for 5 months after the last dose of reslizumab - newly identified protocol-defined adverse events for expedited reporting for reslizumab - new section to describe the capturing of specific adverse events on the eCRF |
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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 | |||
