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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02452190




Registration number
NCT02452190
Ethics application status
Date submitted
13/05/2015
Date registered
22/05/2015
Date last updated
2/01/2020

Titles & IDs
Public title
Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils
Scientific title
A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils
Secondary ID [1] 0 0
2015-000865-29
Secondary ID [2] 0 0
C38072-AS-30025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Reslizumab
Treatment: Drugs - Placebo

Experimental: Reslizumab - Reslizumab

Placebo Comparator: Placebo - Matching Placebo


Treatment: Drugs: Reslizumab
Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

Treatment: Drugs: Placebo
Matching Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment - A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.
Timepoint [1] 0 0
Day 1 to Week 52
Secondary outcome [1] 0 0
Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) - Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.
Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score - AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score - The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night) - Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Percentage of Asthma Control Days - The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [5] 0 0
Day 1 to Week 52
Secondary outcome [6] 0 0
Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score - The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.
Timepoint [6] 0 0
Baseline, Week 32
Secondary outcome [7] 0 0
Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52 - CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit.
The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early.
Timepoint [7] 0 0
Day 1 to Week 52
Secondary outcome [8] 0 0
Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment - A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.
Timepoint [8] 0 0
Day 1 to Week 52
Secondary outcome [9] 0 0
Number of Moderate Exacerbations During 52 Weeks of Treatment - A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.
Timepoint [9] 0 0
Day 1 to Week 52

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78085 - Bedford Park
Recruitment hospital [2] 0 0
Teva Investigational Site 78083 - Nedlands
Recruitment hospital [3] 0 0
Teva Investigational Site 78088 - Parkville
Recruitment hospital [4] 0 0
Teva Investigational Site 78087 - Sherwood
Recruitment hospital [5] 0 0
Teva Investigational Site 78084 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
4075 - Sherwood
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
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Ramat Gan
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Kobe
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Russian Federation
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St. Petersburg
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Russian Federation
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South Africa
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Benoni
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South Africa
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South Africa
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South Africa
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Durban
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Spain
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Barcelona
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Spain
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Esplugues de Llobregat
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Spain
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Girona
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Spain
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Vitoria-Gasteiz
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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Mersin
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kremenchuk
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv
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Ukraine
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Sumy
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Ukraine
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Vinnytsia
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhya
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Ukraine
State/province [148] 0 0
Zhaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02452190
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
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