Clinical trial NCT02501629: An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Elevated Blood Eosinophils
Oral Corticosteroid Dependence
Keywords: Asthma
Elevated Blood Eosinophils
Oral corticosteroid dependence
Reslizumab
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 177
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
timeFrame: Baseline (Day 1), Weeks 20-24
Secondary outcomes:
measure: Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
timeFrame: Baseline (Day 1), Weeks 20-24
measure: Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control
timeFrame: Weeks 20-24
measure: Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures
timeFrame: Baseline (Day 1), Weeks 20-24
measure: Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
timeFrame: Baseline (Day 1), Weeks 20-24
measure: Annualized Rate of Clinical Asthma Exacerbations (CAEs)
timeFrame: Day 1 through Week 24
measure: Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control
timeFrame: Weeks 20-24
measure: Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
timeFrame: Weeks 4, 8, 12, 24 or early withdrawal.
measure: Participants With Adverse Events
timeFrame: 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.
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Teva Investigational Site 13357
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 13365
state: California
city: Clermont
country: United States
facility: Teva Investigational Site 13371
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 13351
state: Florida
city: Kissimmee
country: United States
facility: Teva Investigational Site 13342
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13344
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13372
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13354
state: Florida
city: Saint Cloud
country: United States
facility: Teva Investigational Site 13343
state: Florida
city: Sebring
country: United States
facility: Teva Investigational Site 13368
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 13346
state: Florida
city: Chicago
country: United States
facility: Teva Investigational Site 13367
state: Illinois
city: Normal
country: United States
facility: Teva Investigational Site 13363
state: Illinois
city: Michigan City
country: United States
facility: Teva Investigational Site 13345
state: Indiana
city: Lenexa
country: United States
facility: Teva Investigational Site 13348
state: Kansas
city: Biloxi
country: United States
facility: Teva Investigational Site 13362
state: Mississippi
city: Saint Louis
country: United States
facility: Teva Investigational Site 13350
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 13352
state: Missouri
city: New York
country: United States
facility: Teva Investigational Site 13356
state: New York
city: Cincinnati
country: United States
facility: Teva Investigational Site 13349
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 13370
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13347
state: Oklahoma
city: Charleston
country: United States
facility: Teva Investigational Site 13366
state: South Carolina
city: Dallas
country: United States
facility: Teva Investigational Site 13377
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13369
state: Texas
city: Fairfax
country: United States
facility: Teva Investigational Site 13358
state: Virginia
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20059
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20058
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20056
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20057
city: Cordoba
country: Argentina
facility: Teva Investigational Site 20052
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20055
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20050
city: Rosario
country: Argentina
facility: Teva Investigational Site 20087
city: San Miguel de Tucuman
country: Argentina
facility: Teva Investigational Site 20051
city: San Rafael
country: Argentina
facility: Teva Investigational Site 20066
city: Bedford Park
country: Australia
facility: Teva Investigational Site 78089
city: Box Hill
country: Australia
facility: Teva Investigational Site 78092
city: Frankston
country: Australia
facility: Teva Investigational Site 78097
city: Kent Town
country: Australia
facility: Teva Investigational Site 78093
city: Nedlands
country: Australia
facility: Teva Investigational Site 78090
city: New Lambton
country: Australia
facility: Teva Investigational Site 78091
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 37059
city: Gembloux
country: Belgium
facility: Teva Investigational Site 37058
city: Breclav
country: Czechia
facility: Teva Investigational Site 54133
city: Jindrichuv Hradec
country: Czechia
facility: Teva Investigational Site 54132
city: Le Kremlin-bicetre
country: France
facility: Teva Investigational Site 35186
city: Lille Cedex
country: France
facility: Teva Investigational Site 35185
city: Lyon Cedex 04
country: France
facility: Teva Investigational Site 35189
city: Strasbourg
country: France
facility: Teva Investigational Site 35187
city: Bad Worishofen
country: Germany
facility: Teva Investigational Site 32621
city: Berlin
country: Germany
facility: Teva Investigational Site 32576
city: Berlin
country: Germany
facility: Teva Investigational Site 32573
city: Berlin
country: Germany
facility: Teva Investigational Site 32578
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32622
city: Hannover
country: Germany
facility: Teva Investigational Site 32579
city: Leipzig
country: Germany
facility: Teva Investigational Site 32574
city: Rostock
country: Germany
facility: Teva Investigational Site 32580
city: Csorna
country: Hungary
facility: Teva Investigational Site 51254
city: Dombovar
country: Hungary
facility: Teva Investigational Site 51232
city: Hatvan
country: Hungary
facility: Teva Investigational Site 51233
city: Szombathely
country: Hungary
facility: Teva Investigational Site 51253
city: Haifa
country: Israel
facility: Teva Investigational Site 80085
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80083
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 80091
city: Petah Tikva
country: Israel
facility: Teva Investigational Site 80084
city: Rehovot
country: Israel
facility: Teva Investigational Site 80082
city: Catanzaro
country: Italy
facility: Teva Investigational Site 30152
city: Genova
country: Italy
facility: Teva Investigational Site 30154
city: Goyang-si
country: Korea, Republic of
facility: Teva Investigational Site 87020
city: Jeonju
country: Korea, Republic of
facility: Teva Investigational Site 87024
city: Seongnam-si
country: Korea, Republic of
facility: Teva Investigational Site 87025
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87023
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87022
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87021
city: Chihuahua
country: Mexico
facility: Teva Investigational Site 21106
city: Distrito Federal
country: Mexico
facility: Teva Investigational Site 21102
city: Durango
country: Mexico
facility: Teva Investigational Site 21104
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21094
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21091
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21100
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21093
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21090
city: Monterrey
country: Mexico
facility: Teva Investigational Site 21103
city: Monterrey
country: Mexico
facility: Teva Investigational Site 21101
city: Queretaro
country: Mexico
facility: Teva Investigational Site 21105
city: Leeuwarden
country: Netherlands
facility: Teva Investigational Site 38084
city: Zwolle
country: Netherlands
facility: Teva Investigational Site 38085
city: Gdansk
country: Poland
facility: Teva Investigational Site 53316
city: Krakow
country: Poland
facility: Teva Investigational Site 53318
city: Lodz
country: Poland
facility: Teva Investigational Site 53319
city: Lodz
country: Poland
facility: Teva Investigational Site 53321
city: Lubin
country: Poland
facility: Teva Investigational Site 53322
city: Ostrow Wielkopolski
country: Poland
facility: Teva Investigational Site 53320
city: Rzeszow
country: Poland
facility: Teva Investigational Site 53358
city: Tarnow
country: Poland
facility: Teva Investigational Site 53317
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53323
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 50356
city: Chelyabinsk
country: Russian Federation
facility: Teva Investigational Site 50417
city: Ekaterinburg
country: Russian Federation
facility: Teva Investigational Site 50419
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50385
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50382
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50384
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50383
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50386
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50357
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50418
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50358
city: Barcelona
country: Spain
facility: Teva Investigational Site 31159
city: Girona
country: Spain
facility: Teva Investigational Site 31161
city: Valencia
country: Spain
facility: Teva Investigational Site 31160
city: Valencia
country: Spain
facility: Teva Investigational Site 31158
city: Dnepropetrovsk
country: Ukraine
facility: Teva Investigational Site 58245
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58238
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58240
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58244
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58235
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58239
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58241
city: Kremenchuk
country: Ukraine
facility: Teva Investigational Site 58249
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58248
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58251
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58237
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58250
city: Sumy
country: Ukraine
facility: Teva Investigational Site 58243
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 58246
city: Zhaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58242
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.