Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2015-001580-39
Query!
Secondary ID [2]
0
0
C38072-AS-30027
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Elevated Blood Eosinophils
0
0
Query!
Oral Corticosteroid Dependence
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Day 1), Weeks 20-24
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Day 1), Weeks 20-24
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Weeks 20-24
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline (Day 1), Weeks 20-24
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline (Day 1), Weeks 20-24
Query!
Secondary outcome [5]
0
0
Annualized Rate of Clinical Asthma Exacerbations (CAEs)
Query!
Assessment method [5]
0
0
The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.
Query!
Timepoint [5]
0
0
Day 1 through Week 24
Query!
Secondary outcome [6]
0
0
Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Weeks 20-24
Query!
Secondary outcome [7]
0
0
Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Weeks 4, 8, 12, 24 or early withdrawal.
Query!
Secondary outcome [8]
0
0
Participants With Adverse Events
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
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.
Query!
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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/09/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
4/12/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
177
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Teva Investigational Site 78089 - Bedford Park
Query!
Recruitment hospital [2]
0
0
Teva Investigational Site 78092 - Box Hill
Query!
Recruitment hospital [3]
0
0
Teva Investigational Site 78097 - Frankston
Query!
Recruitment hospital [4]
0
0
Teva Investigational Site 78093 - Kent Town
Query!
Recruitment hospital [5]
0
0
Teva Investigational Site 78090 - Nedlands
Query!
Recruitment hospital [6]
0
0
Teva Investigational Site 78091 - New Lambton
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [3]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [4]
0
0
5067 - Kent Town
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [6]
0
0
2305 - New Lambton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Mississippi
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oklahoma
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Cordoba
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Mendoza
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Rosario
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
San Miguel de Tucuman
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
San Rafael
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Bruxelles
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Gembloux
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Breclav
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Jindrichuv Hradec
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Le Kremlin-bicetre
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Lille Cedex
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Lyon Cedex 04
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Strasbourg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Bad Worishofen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Berlin
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Frankfurt
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hannover
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Leipzig
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Rostock
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Csorna
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Dombovar
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Hatvan
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Szombathely
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Haifa
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Jerusalem
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Kfar Saba
Query!
Country [41]
0
0
Israel
Query!
State/province [41]
0
0
Petah Tikva
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Rehovot
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Catanzaro
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Genova
Query!
Country [45]
0
0
Korea, Republic of
Query!
State/province [45]
0
0
Goyang-si
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Jeonju
Query!
Country [47]
0
0
Korea, Republic of
Query!
State/province [47]
0
0
Seongnam-si
Query!
Country [48]
0
0
Korea, Republic of
Query!
State/province [48]
0
0
Seoul
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Chihuahua
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Distrito Federal
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Durango
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Guadalajara
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Mexico City
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Monterrey
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Queretaro
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Leeuwarden
Query!
Country [57]
0
0
Netherlands
Query!
State/province [57]
0
0
Zwolle
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Gdansk
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Krakow
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lodz
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Lubin
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Ostrow Wielkopolski
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Rzeszow
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Tarnow
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wroclaw
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Barnaul
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Chelyabinsk
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Ekaterinburg
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Kemerovo
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Moscow
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Novosibirsk
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
St. Petersburg
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Tomsk
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Barcelona
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Girona
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Valencia
Query!
Country [77]
0
0
Ukraine
Query!
State/province [77]
0
0
Dnepropetrovsk
Query!
Country [78]
0
0
Ukraine
Query!
State/province [78]
0
0
Dnipropetrovsk
Query!
Country [79]
0
0
Ukraine
Query!
State/province [79]
0
0
Ivano-Frankivsk
Query!
Country [80]
0
0
Ukraine
Query!
State/province [80]
0
0
Kharkiv
Query!
Country [81]
0
0
Ukraine
Query!
State/province [81]
0
0
Kremenchuk
Query!
Country [82]
0
0
Ukraine
Query!
State/province [82]
0
0
Kyiv
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Sumy
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Vinnytsya
Query!
Country [85]
0
0
Ukraine
Query!
State/province [85]
0
0
Zhaporizhzhya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02501629
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Teva Medical Expert, MD
Query!
Address
0
0
Teva Branded Pharmaceutical Products R&D, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02501629
Download to PDF