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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
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California
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Florida
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Illinois
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Indiana
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Kansas
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Mississippi
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Missouri
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New York
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Ohio
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Oklahoma
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South Carolina
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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San Rafael
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Belgium
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Bruxelles
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Belgium
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Gembloux
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Czechia
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Breclav
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Czechia
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Jindrichuv Hradec
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France
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Lille Cedex
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Lyon Cedex 04
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France
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Strasbourg
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Germany
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Frankfurt
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Hannover
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Leipzig
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Germany
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Rostock
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Hungary
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Csorna
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Hungary
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Dombovar
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Hatvan
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Szombathely
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Rehovot
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Italy
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Catanzaro
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Genova
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Distrito Federal
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Mexico City
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Monterrey
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Queretaro
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Netherlands
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Zwolle
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Gdansk
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Krakow
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Lodz
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Lubin
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Ostrow Wielkopolski
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Rzeszow
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Tarnow
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Wroclaw
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Valencia
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Ukraine
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Dnepropetrovsk
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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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Kyiv
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Ukraine
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Sumy
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Ukraine
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT02501629
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/NCT02501629