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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02452190
Ethics application status
Date submitted
13/05/2015
Date registered
22/05/2015
Date last updated
9/11/2021

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
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)
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
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
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)
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Percentage of Asthma Control Days
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
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
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
Timepoint [8] 0 0
Day 1 to Week 52
Secondary outcome [9] 0 0
Number of Moderate Exacerbations During 52 Weeks of Treatment
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
Sex
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
28/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
Accrual to date
Final
468
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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Tomsk
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Benoni
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South Africa
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Bloemfontein
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South Africa
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Cape Town
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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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Esplugues de Llobregat
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Spain
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Girona
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Vitoria-Gasteiz
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Izmir
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Konya
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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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Kharkiv
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Kremenchuk
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Ukraine
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Kryvyi Rih
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Kyiv
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Sumy
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Vinnytsia
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Vinnytsya
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Ukraine
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Zaporizhzhya
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Ukraine
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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/study/NCT02452190
Trial related presentations / publications
Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02452190