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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02501629
Registration number
NCT02501629
Ethics application status
Date submitted
14/07/2015
Date registered
17/07/2015
Date last updated
9/11/2021
Titles & IDs
Public title
An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
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Scientific title
A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
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Secondary ID [1]
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2015-001580-39
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Secondary ID [2]
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C38072-AS-30027
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Elevated Blood Eosinophils
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Oral Corticosteroid Dependence
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Reslizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Non-Oral Corticosteroid (non-OCS) Asthma Medication
Treatment: Drugs - Oral Corticosteroid (OCS)
Experimental: Reslizumab 110 mg - Reslizumab was administered by subcutaneous injection (sc) in a dosage of 110 mg (1.0 mL) every 4 weeks for a total of six doses.
Placebo comparator: Placebo - Matching placebo was administered by subcutaneous injection (sc) 1.0 mL every 4 weeks for a total of six doses.
Treatment: Drugs: Reslizumab
Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
Treatment: Drugs: Placebo
Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
Treatment: Drugs: Non-Oral Corticosteroid (non-OCS) Asthma Medication
Participants continue using their non-OCS background asthma medications without change during the study's treatment period.
Treatment: Drugs: Oral Corticosteroid (OCS)
After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
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Assessment method [1]
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The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders.
No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.
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Timepoint [1]
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Baseline (Day 1), Weeks 20-24
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Secondary outcome [1]
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Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
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Assessment method [1]
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Percentage of patients whose OCS dose at weeks 20-24 was reduced \>=50% compared to baseline while maintaining asthma control.
Patients listed as "no" did not achieve the 50% reduction in baseline OCS dose goal, or did achieve that goal but lost asthma control during weeks 20 to 24, or discontinued from study drug.
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Timepoint [1]
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Baseline (Day 1), Weeks 20-24
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Secondary outcome [2]
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Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control
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Assessment method [2]
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Percentage of participants whose OCS dose at weeks 20-24 was \<=5 mg and they maintained asthma control.
Patients listed as "no" had a week 20-24 OCS dose \> 5 mg, or whose OCS dose was \<=5 mg at weeks 20-24 but did not maintain asthma control, or they discontinued from study drug.
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Timepoint [2]
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Weeks 20-24
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Secondary outcome [3]
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Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures
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Assessment method [3]
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The baseline OCS dose is the prescribed optimized OCS dose following the OCS optimization period. Endpoint data are presented using an on-treatment approach. In this context, 'endpoint' was defined as the last observation obtained at a scheduled or qualified early termination visit during the treatment period. Weeks 20-24 data is included between the Week 20 dose and Week 24 for completed patients; last dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Measurements collected outside of these defined timeframes are excluded from the analyses.
The mixed model repeated measures (MMRM) included fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.
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Timepoint [3]
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Baseline (Day 1), Weeks 20-24
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Secondary outcome [4]
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Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
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Assessment method [4]
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Percentage of participants whose OCS dose at weeks 20-24 was reduced by at least 5mg from baseline and maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose that did not meet the threshold of a 5mg reduction, or whose OCS dose met the threshold but did not maintain asthma control, or discontinued from study drug.
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Timepoint [4]
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Baseline (Day 1), Weeks 20-24
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Secondary outcome [5]
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Annualized Rate of Clinical Asthma Exacerbations (CAEs)
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Assessment method [5]
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The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.
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Timepoint [5]
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Day 1 through Week 24
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Secondary outcome [6]
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Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control
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Assessment method [6]
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Percentage of participants who discontinue use of OCS during weeks 20-24 while maintaining asthma control.
Patients listed as "no" continued to use OCS during weeks 20-24, or who discontinued use of OCS during weeks 20-24 but lost control of their asthma, or discontinued from study drug.
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Timepoint [6]
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Weeks 20-24
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Secondary outcome [7]
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Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
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Assessment method [7]
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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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Timepoint [7]
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Weeks 4, 8, 12, 24 or early withdrawal.
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Secondary outcome [8]
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Participants With Adverse Events
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Assessment method [8]
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An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. In this study, asthma exacerbations (which are efficacy parameters) should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. 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.
Treatment-related adverse events or adverse events related to OCS use included events with missing relationship to study drug or OCS use, respectively.
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Timepoint [8]
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Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.
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Eligibility
Key inclusion criteria
1. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
2. Written informed consent is obtained.
3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
4. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
5. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.
* Other criteria may apply, please contact the investigator for more information.
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Minimum age
12
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
2. The patient has another confounding underlying lung disorder.
3. The patient has a known hypereosinophilic syndrome.
4. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
5. The patient is pregnant or intends to become pregnant during the study or is lactating.
6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
7. The patient is a current smoker or has a smoking history =10 pack-years.
8. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
9. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
10. The patient was previously exposed to benralizumab within 12 months of screening.
11. The patient was previously exposed to reslizumab.
12. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
13. The patient has current suspected drug and/or alcohol abuse.
14. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
15. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.
* Other criteria may apply, please contact the investigator for more information.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2017
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Sample size
Target
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Accrual to date
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Final
177
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Teva Investigational Site 78089 - Bedford Park
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Recruitment hospital [2]
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Teva Investigational Site 78092 - Box Hill
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Teva Investigational Site 78097 - Frankston
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Teva Investigational Site 78093 - Kent Town
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Teva Investigational Site 78090 - Nedlands
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Recruitment hospital [6]
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Teva Investigational Site 78091 - New Lambton
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3128 - Box Hill
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3199 - Frankston
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5067 - Kent Town
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6009 - Nedlands
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Recruitment postcode(s) [6]
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2305 - New Lambton
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Recruitment outside Australia
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Zhaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Teva Branded Pharmaceutical Products R&D, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.
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Trial website
https://clinicaltrials.gov/study/NCT02501629
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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.
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Teva Medical Expert, MD
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Teva Branded Pharmaceutical Products R&D, Inc.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/29/NCT02501629/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT02501629/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02501629
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