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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
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
Secondary ID [1] 0 0
2015-001580-39
Secondary ID [2] 0 0
C38072-AS-30027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Elevated Blood Eosinophils 0 0
Oral Corticosteroid Dependence 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
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Baseline (Day 1), Weeks 20-24
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
Timepoint [1] 0 0
Baseline (Day 1), Weeks 20-24
Secondary outcome [2] 0 0
Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control
Timepoint [2] 0 0
Weeks 20-24
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
Timepoint [3] 0 0
Baseline (Day 1), Weeks 20-24
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
Timepoint [4] 0 0
Baseline (Day 1), Weeks 20-24
Secondary outcome [5] 0 0
Annualized Rate of Clinical Asthma Exacerbations (CAEs)
Timepoint [5] 0 0
Day 1 through Week 24
Secondary outcome [6] 0 0
Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control
Timepoint [6] 0 0
Weeks 20-24
Secondary outcome [7] 0 0
Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
Timepoint [7] 0 0
Weeks 4, 8, 12, 24 or early withdrawal.
Secondary outcome [8] 0 0
Participants With Adverse Events
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.

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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
29/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2017
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78089 - Bedford Park
Recruitment hospital [2] 0 0
Teva Investigational Site 78092 - Box Hill
Recruitment hospital [3] 0 0
Teva Investigational Site 78097 - Frankston
Recruitment hospital [4] 0 0
Teva Investigational Site 78093 - Kent Town
Recruitment hospital [5] 0 0
Teva Investigational Site 78090 - Nedlands
Recruitment hospital [6] 0 0
Teva Investigational Site 78091 - New Lambton
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
5067 - Kent Town
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2305 - New Lambton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Mendoza
Country [17] 0 0
Argentina
State/province [17] 0 0
Rosario
Country [18] 0 0
Argentina
State/province [18] 0 0
San Miguel de Tucuman
Country [19] 0 0
Argentina
State/province [19] 0 0
San Rafael
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gembloux
Country [22] 0 0
Czechia
State/province [22] 0 0
Breclav
Country [23] 0 0
Czechia
State/province [23] 0 0
Jindrichuv Hradec
Country [24] 0 0
France
State/province [24] 0 0
Le Kremlin-bicetre
Country [25] 0 0
France
State/province [25] 0 0
Lille Cedex
Country [26] 0 0
France
State/province [26] 0 0
Lyon Cedex 04
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
Germany
State/province [28] 0 0
Bad Worishofen
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Hannover
Country [32] 0 0
Germany
State/province [32] 0 0
Leipzig
Country [33] 0 0
Germany
State/province [33] 0 0
Rostock
Country [34] 0 0
Hungary
State/province [34] 0 0
Csorna
Country [35] 0 0
Hungary
State/province [35] 0 0
Dombovar
Country [36] 0 0
Hungary
State/province [36] 0 0
Hatvan
Country [37] 0 0
Hungary
State/province [37] 0 0
Szombathely
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Kfar Saba
Country [41] 0 0
Israel
State/province [41] 0 0
Petah Tikva
Country [42] 0 0
Israel
State/province [42] 0 0
Rehovot
Country [43] 0 0
Italy
State/province [43] 0 0
Catanzaro
Country [44] 0 0
Italy
State/province [44] 0 0
Genova
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Goyang-si
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Jeonju
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seongnam-si
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Mexico
State/province [49] 0 0
Chihuahua
Country [50] 0 0
Mexico
State/province [50] 0 0
Distrito Federal
Country [51] 0 0
Mexico
State/province [51] 0 0
Durango
Country [52] 0 0
Mexico
State/province [52] 0 0
Guadalajara
Country [53] 0 0
Mexico
State/province [53] 0 0
Mexico City
Country [54] 0 0
Mexico
State/province [54] 0 0
Monterrey
Country [55] 0 0
Mexico
State/province [55] 0 0
Queretaro
Country [56] 0 0
Netherlands
State/province [56] 0 0
Leeuwarden
Country [57] 0 0
Netherlands
State/province [57] 0 0
Zwolle
Country [58] 0 0
Poland
State/province [58] 0 0
Gdansk
Country [59] 0 0
Poland
State/province [59] 0 0
Krakow
Country [60] 0 0
Poland
State/province [60] 0 0
Lodz
Country [61] 0 0
Poland
State/province [61] 0 0
Lubin
Country [62] 0 0
Poland
State/province [62] 0 0
Ostrow Wielkopolski
Country [63] 0 0
Poland
State/province [63] 0 0
Rzeszow
Country [64] 0 0
Poland
State/province [64] 0 0
Tarnow
Country [65] 0 0
Poland
State/province [65] 0 0
Wroclaw
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Barnaul
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Chelyabinsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ekaterinburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Kemerovo
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Novosibirsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
St. Petersburg
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Tomsk
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Girona
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Ukraine
State/province [77] 0 0
Dnepropetrovsk
Country [78] 0 0
Ukraine
State/province [78] 0 0
Dnipropetrovsk
Country [79] 0 0
Ukraine
State/province [79] 0 0
Ivano-Frankivsk
Country [80] 0 0
Ukraine
State/province [80] 0 0
Kharkiv
Country [81] 0 0
Ukraine
State/province [81] 0 0
Kremenchuk
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kyiv
Country [83] 0 0
Ukraine
State/province [83] 0 0
Sumy
Country [84] 0 0
Ukraine
State/province [84] 0 0
Vinnytsya
Country [85] 0 0
Ukraine
State/province [85] 0 0
Zhaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02501629