Clinical trial NCT02452190: Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils
Official title: A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2015-05-22
Enrollment: 468
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 this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent is obtained.
* The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
* The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
* The participant has required an inhaled corticosteroid.
* The participant has required an additional asthma controller medication besides inhaled corticosteroids.
* The participant has a history of asthma exacerbation.
* The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

  * Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

* The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
* The participant has another confounding underlying lung disorder
* The participant has a known hypereosinophilic syndrome.
* The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
* The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
* The participant is a current smoker or has a smoking history.
* The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
* The participant was previously exposed to reslizumab.
* The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
* The participant has current or suspected drug and alcohol abuse.
* The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
* The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.

  * Additional criteria may apply, please contact the investigator for more information

Primary outcomes:
measure: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment
timeFrame: Day 1 to Week 52
Secondary outcomes:
measure: Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)
timeFrame: Baseline, Week 52
measure: Percentage of Asthma Control Days
timeFrame: Day 1 to Week 52
measure: Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Baseline, Week 32
measure: Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52
timeFrame: Day 1 to Week 52
measure: Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment
timeFrame: Day 1 to Week 52
measure: Number of Moderate Exacerbations During 52 Weeks of Treatment
timeFrame: Day 1 to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 13212
state: Alabama
city: Flagstaff
country: United States
facility: Teva Investigational Site 13241
state: Arizona
city: Glendale
country: United States
facility: Teva Investigational Site 13194
state: Arkansas
city: Bakersfield
country: United States
facility: Teva Investigational Site 13215
state: California
city: Canoga Park
country: United States
facility: Teva Investigational Site 13181
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 13254
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 13216
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 13247
state: California
city: Napa
country: United States
facility: Teva Investigational Site 13205
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 13764
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 13252
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 13251
state: California
city: Denver
country: United States
facility: Teva Investigational Site 13229
state: Colorado
city: Waterbury
country: United States
facility: Teva Investigational Site 13766
state: Connecticut
city: Aventura
country: United States
facility: Teva Investigational Site 13196
state: Florida
city: Fort Lauderdale
country: United States
facility: Teva Investigational Site 13256
state: Florida
city: Kissimmee
country: United States
facility: Teva Investigational Site 13203
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13197
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13220
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13243
state: Florida
city: New Port Richey
country: United States
facility: Teva Investigational Site 13233
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13201
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13250
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13246
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 13208
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 13255
state: Florida
city: Albany
country: United States
facility: Teva Investigational Site 13765
state: Georgia
city: Buford
country: United States
facility: Teva Investigational Site 13249
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Investigational Site 13763
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 13230
state: Illinois
city: Normal
country: United States
facility: Teva Investigational Site 13211
state: Illinois
city: Shiloh
country: United States
facility: Teva Investigational Site 13235
state: Illinois
city: Michigan City
country: United States
facility: Teva Investigational Site 13202
state: Indiana
city: Lenexa
country: United States
facility: Teva Investigational Site 13225
state: Kansas
city: Owensboro
country: United States
facility: Teva Investigational Site 13222
state: Kentucky
city: Lafayette
country: United States
facility: Teva Investigational Site 13191
state: Louisiana
city: North Dartmouth
country: United States
facility: Teva Investigational Site 13200
state: Massachusetts
city: Biloxi
country: United States
facility: Teva Investigational Site 13226
state: Mississippi
city: Saint Louis
country: United States
facility: Teva Investigational Site 13204
state: Missouri
city: Boys Town
country: United States
facility: Teva Investigational Site 13258
state: Nebraska
city: Belleville
country: United States
facility: Teva Investigational Site 13769
state: New Jersey
city: Ocean City
country: United States
facility: Teva Investigational Site 13210
state: New Jersey
city: New Hyde Park
country: United States
facility: Teva Investigational Site 13188
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13232
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13767
state: New York
city: Cincinnati
country: United States
facility: Teva Investigational Site 13186
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 13253
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 13240
state: Ohio
city: Edmond
country: United States
facility: Teva Investigational Site 13259
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13238
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 13195
state: Oregon
city: Bethlehem
country: United States
facility: Teva Investigational Site 13242
state: Pennsylvania
city: Jenkintown
country: United States
facility: Teva Investigational Site 13218
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 13189
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 13190
state: Pennsylvania
city: East Providence
country: United States
facility: Teva Investigational Site 13209
state: Rhode Island
city: Lincoln
country: United States
facility: Teva Investigational Site 13217
state: Rhode Island
city: Knoxville
country: United States
facility: Teva Investigational Site 13223
state: Tennessee
city: Arlington
country: United States
facility: Teva Investigational Site 13185
state: Texas
city: Corsicana
country: United States
facility: Teva Investigational Site 13199
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13260
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13224
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 13184
state: Texas
city: Provo
country: United States
facility: Teva Investigational Site 13187
state: Utah
city: Abingdon
country: United States
facility: Teva Investigational Site 13207
state: Virginia
city: Fairfax
country: United States
facility: Teva Investigational Site 13183
state: Virginia
city: Falls Church
country: United States
facility: Teva Investigational Site 13257
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 13239
state: Virginia
city: Spokane
country: United States
facility: Teva Investigational Site 13227
state: Washington
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20040
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20033
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20035
city: Cordoba
country: Argentina
facility: Teva Investigational Site 20041
city: Lanus
country: Argentina
facility: Teva Investigational Site 20053
city: Mar Del Plata
country: Argentina
facility: Teva Investigational Site 20037
city: Mendoza
country: Argentina
facility: Teva Investigational Site 20036
city: Rosario
country: Argentina
facility: Teva Investigational Site 20054
city: Rosario
country: Argentina
facility: Teva Investigational Site 20032
city: San Miguel de Tucuman
country: Argentina
facility: Teva Investigational Site 20046
city: San Rafael
country: Argentina
facility: Teva Investigational Site 20045
city: Bedford Park
country: Australia
facility: Teva Investigational Site 78085
city: Nedlands
country: Australia
facility: Teva Investigational Site 78083
city: Parkville
country: Australia
facility: Teva Investigational Site 78088
city: Sherwood
country: Australia
facility: Teva Investigational Site 78087
city: Woolloongabba
country: Australia
facility: Teva Investigational Site 78084
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 37054
city: Erpent
country: Belgium
facility: Teva Investigational Site 37053
city: Gent
country: Belgium
facility: Teva Investigational Site 37055
city: Vancouver
country: Canada
facility: Teva Investigational Site 11106
state: British Columbia
city: Etobicoke
country: Canada
facility: Teva Investigational Site 11105
state: Ontario
city: Windsor
country: Canada
facility: Teva Investigational Site 11109
city: Jablonec nad Nisou
country: Czechia
facility: Teva Investigational Site 54130
city: Jindrichuv Hradec
country: Czechia
facility: Teva Investigational Site 54128
city: Tabor
country: Czechia
facility: Teva Investigational Site 54129
city: Strasbourg
country: France
facility: Teva Investigational Site 35182
city: Toulouse
country: France
facility: Teva Investigational Site 35183
city: Bad Worishofen
country: Germany
facility: Teva Investigational Site 32559
city: Berlin
country: Germany
facility: Teva Investigational Site 32556
city: Berlin
country: Germany
facility: Teva Investigational Site 32561
city: Berlin
country: Germany
facility: Teva Investigational Site 32570
city: Berlin
country: Germany
facility: Teva Investigational Site 32567
city: Berlin
country: Germany
facility: Teva Investigational Site 32564
city: Frankfurt am Main
country: Germany
facility: Teva Investigational Site 32560
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32568
city: Hamburg
country: Germany
facility: Teva Investigational Site 32562
city: Hannover
country: Germany
facility: Teva Investigational Site 32566
city: Koblenz
country: Germany
facility: Teva Investigational Site 32555
city: Leipzig
country: Germany
facility: Teva Investigational Site 32563
city: Leipzig
country: Germany
facility: Teva Investigational Site 32557
city: Lubeck
country: Germany
facility: Teva Investigational Site 32565
city: Mainz
country: Germany
facility: Teva Investigational Site 32551
city: Witten
country: Germany
facility: Teva Investigational Site 32569
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 51216
city: Budapest
country: Hungary
facility: Teva Investigational Site 51228
city: Csorna
country: Hungary
facility: Teva Investigational Site 51221
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51220
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51223
city: Dombovar
country: Hungary
facility: Teva Investigational Site 51255
city: Godollo
country: Hungary
facility: Teva Investigational Site 51218
city: Gyor
country: Hungary
facility: Teva Investigational Site 51222
city: Hajdunanas
country: Hungary
facility: Teva Investigational Site 51227
city: Kaposvar
country: Hungary
facility: Teva Investigational Site 51226
city: Kapuvar
country: Hungary
facility: Teva Investigational Site 51231
city: Szazhalombatta
country: Hungary
facility: Teva Investigational Site 51224
city: Szeged
country: Hungary
facility: Teva Investigational Site 51219
city: Szigetvar
country: Hungary
facility: Teva Investigational Site 51225
city: Szombathely
country: Hungary
facility: Teva Investigational Site 51217
city: Veszprem
country: Hungary
facility: Teva Investigational Site 51229
city: Ashkelon
country: Israel
facility: Teva Investigational Site 80077
city: Haifa
country: Israel
facility: Teva Investigational Site 80076
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80094
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80078
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 80080
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 80073
city: Petah Tikva
country: Israel
facility: Teva Investigational Site 80081
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80079
city: Rehovot
country: Israel
facility: Teva Investigational Site 80075
city: Amagasaki
country: Japan
facility: Teva Investigational Site 84039
city: Ginowan
country: Japan
facility: Teva Investigational Site 84053
city: Hakodate
country: Japan
facility: Teva Investigational Site 84049
city: Hiroshima
country: Japan
facility: Teva Investigational Site 84034
city: Kanazawa-shi
country: Japan
facility: Teva Investigational Site 84036
city: Kishiwada-shi
country: Japan
facility: Teva Investigational Site 84037
city: Kobe
country: Japan
facility: Teva Investigational Site 84048
city: Kobe
country: Japan
facility: Teva Investigational Site 84044
city: Kodaira
country: Japan
facility: Teva Investigational Site 84047
city: Kumamoto
country: Japan
facility: Teva Investigational Site 84045
city: Mizunami-shi
country: Japan
facility: Teva Investigational Site 84043
city: Sagamihara
country: Japan
facility: Teva Investigational Site 84041
city: Tokyo
country: Japan
facility: Teva Investigational Site 84031
city: Tokyo
country: Japan
facility: Teva Investigational Site 84032
city: Toyama-shi
country: Japan
facility: Teva Investigational Site 84038
city: Toyama
country: Japan
facility: Teva Investigational Site 84046
city: Toyoake-shi
country: Japan
facility: Teva Investigational Site 84035
city: Yokohama-shi
country: Japan
facility: Teva Investigational Site 84040
city: Bucheon
country: Korea, Republic of
facility: Teva Investigational Site 87015
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87016
city: Seoul
country: Korea, Republic of
facility: Teva Investigational Site 87014
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21084
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21085
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21088
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21089
city: Monterrey
country: Mexico
facility: Teva Investigational Site 21087
city: Zapopan
country: Mexico
facility: Teva Investigational Site 21086
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79047
city: Auckland
country: New Zealand
facility: Teva Investigational Site 79046
city: Bialystok
country: Poland
facility: Teva Investigational Site 53310
city: Bialystok
country: Poland
facility: Teva Investigational Site 53315
city: Gdansk
country: Poland
facility: Teva Investigational Site 53308
city: Krakow
country: Poland
facility: Teva Investigational Site 53311
city: Lodz
country: Poland
facility: Teva Investigational Site 53314
city: Lodz
country: Poland
facility: Teva Investigational Site 53312
city: Poznan
country: Poland
facility: Teva Investigational Site 53313
city: Tarnow
country: Poland
facility: Teva Investigational Site 53309
city: Brasov
country: Romania
facility: Teva Investigational Site 52108
city: Brasov
country: Romania
facility: Teva Investigational Site 52109
city: Bucharest
country: Romania
facility: Teva Investigational Site 52107
city: Bucharest
country: Romania
facility: Teva Investigational Site 52105
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 52104
city: Deva
country: Romania
facility: Teva Investigational Site 52111
city: Targu Mures
country: Romania
facility: Teva Investigational Site 52106
city: Timisoara
country: Romania
facility: Teva Investigational Site 52110
city: Barnaul
country: Russian Federation
facility: Teva Investigational Site 50350
city: Kemerovo
country: Russian Federation
facility: Teva Investigational Site 50354
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50348
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50351
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50347
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50355
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50352
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50349
city: Benoni
country: South Africa
facility: Teva Investigational Site 90027
city: Bloemfontein
country: South Africa
facility: Teva Investigational Site 90028
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90026
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90031
city: Cape Town
country: South Africa
facility: Teva Investigational Site 90029
city: Durban
country: South Africa
facility: Teva Investigational Site 90032
city: Durban
country: South Africa
facility: Teva Investigational Site 90030
city: Barcelona
country: Spain
facility: Teva Investigational Site 31149
city: Esplugues de Llobregat
country: Spain
facility: Teva Investigational Site 31147
city: Girona
country: Spain
facility: Teva Investigational Site 31152
city: Vitoria-Gasteiz
country: Spain
facility: Teva Investigational Site 31154
city: Ankara
country: Turkey
facility: Teva Investigational Site 82042
city: Izmir
country: Turkey
facility: Teva Investigational Site 82041
city: Kocaeli
country: Turkey
facility: Teva Investigational Site 82040
city: Konya
country: Turkey
facility: Teva Investigational Site 82039
city: Mersin
country: Turkey
facility: Teva Investigational Site 82043
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 58216
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58219
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58225
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 58222
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58227
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58213
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58221
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58223
city: Kremenchuk
country: Ukraine
facility: Teva Investigational Site 58214
city: Kryvyi Rih
country: Ukraine
facility: Teva Investigational Site 58228
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58220
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58230
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58218
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58226
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58253
city: Sumy
country: Ukraine
facility: Teva Investigational Site 58234
city: Vinnytsia
country: Ukraine
facility: Teva Investigational Site 58233
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 58229
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58231
city: Zhaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58224
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.